Trial Outcomes & Findings for Evaluation of Galcanezumab in the Prevention of Chronic Migraine (NCT NCT02614261)
NCT ID: NCT02614261
Last Updated: 2022-05-18
Results Overview
MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1117 participants
Primary outcome timeframe
Baseline, Month 1 through Month 3
Results posted on
2022-05-18
Participant Flow
1. Main study: This randomised part of study was conducted in 3 phases * a 3-month double-blind treatment phase * an optional 9-month open-label extension phase * a 4-month follow-up phase 2. Israel addendum: Participants in Israel who completed all phases in main study, benefited from galcanezumab and had no other suitable alternative treatment options available were provided continued-access to galcanezumab where safety was monitored.
Participant milestones
| Measure |
Placebo
* Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg
* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg
* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Israel Addendum
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
|
|---|---|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
559
|
279
|
279
|
0
|
|
Double-Blind Treatment Phase
Received at Least One Dose of Study Drug
|
558
|
278
|
277
|
0
|
|
Double-Blind Treatment Phase
Safety Population
|
558
|
273
|
282
|
0
|
|
Double-Blind Treatment Phase
COMPLETED
|
509
|
262
|
266
|
0
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
50
|
17
|
13
|
0
|
|
Open-Label Extension Phase
STARTED
|
501
|
259
|
262
|
0
|
|
Open-Label Extension Phase
Safety Population
|
501
|
259
|
262
|
0
|
|
Open-Label Extension Phase
COMPLETED
|
413
|
204
|
208
|
0
|
|
Open-Label Extension Phase
NOT COMPLETED
|
88
|
55
|
54
|
0
|
|
Follow-up Phase
STARTED
|
453
|
228
|
231
|
0
|
|
Follow-up Phase
Entered From Double-blind Treatment Phase
|
15
|
5
|
3
|
0
|
|
Follow-up Phase
Safety Population (Entered From Double-blind Treatment Phase)
|
15
|
4
|
4
|
0
|
|
Follow-up Phase
Entered From Open-label Extension Phase
|
438
|
223
|
228
|
0
|
|
Follow-up Phase
Safety Population (Entered From Open-label Extension Phase)
|
438
|
223
|
228
|
0
|
|
Follow-up Phase
COMPLETED
|
421
|
217
|
217
|
0
|
|
Follow-up Phase
NOT COMPLETED
|
32
|
11
|
14
|
0
|
|
Israel Addendum
STARTED
|
0
|
0
|
0
|
29
|
|
Israel Addendum
Safety Population
|
0
|
0
|
0
|
29
|
|
Israel Addendum
COMPLETED
|
0
|
0
|
0
|
25
|
|
Israel Addendum
NOT COMPLETED
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo
* Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg
* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg
* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Israel Addendum
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
|
|---|---|---|---|---|
|
Double-Blind Treatment Phase
Adverse Event
|
7
|
3
|
2
|
0
|
|
Double-Blind Treatment Phase
Lack of Efficacy
|
4
|
0
|
0
|
0
|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
9
|
4
|
1
|
0
|
|
Double-Blind Treatment Phase
Physician Decision
|
2
|
1
|
1
|
0
|
|
Double-Blind Treatment Phase
Pregnancy
|
2
|
2
|
0
|
0
|
|
Double-Blind Treatment Phase
Protocol Violation
|
6
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Screen failure
|
0
|
1
|
2
|
0
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
20
|
5
|
7
|
0
|
|
Open-Label Extension Phase
Adverse Event
|
23
|
12
|
11
|
0
|
|
Open-Label Extension Phase
Lack of Efficacy
|
14
|
12
|
14
|
0
|
|
Open-Label Extension Phase
Lost to Follow-up
|
15
|
7
|
9
|
0
|
|
Open-Label Extension Phase
Physician Decision
|
2
|
0
|
0
|
0
|
|
Open-Label Extension Phase
Pregnancy
|
1
|
2
|
1
|
0
|
|
Open-Label Extension Phase
Protocol Violation
|
3
|
4
|
1
|
0
|
|
Open-Label Extension Phase
Withdrawal by Subject
|
30
|
18
|
18
|
0
|
|
Follow-up Phase
Adverse Event
|
2
|
0
|
1
|
0
|
|
Follow-up Phase
Lost to Follow-up
|
12
|
5
|
2
|
0
|
|
Follow-up Phase
Physician Decision
|
5
|
1
|
0
|
0
|
|
Follow-up Phase
Pregnancy
|
0
|
1
|
0
|
0
|
|
Follow-up Phase
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Follow-up Phase
Withdrawal by Subject
|
12
|
4
|
11
|
0
|
|
Israel Addendum
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
Baseline Characteristics
All randomized participants who received at least one dose of study drug.
Baseline characteristics by cohort
| Measure |
Placebo
n=559 Participants
* Double-blind treatment phase: Participants received placebo once a month by subcutaneous injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg
n=279 Participants
* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg
n=279 Participants
* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Total
n=1117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.61 years
STANDARD_DEVIATION 12.07 • n=559 Participants
|
39.66 years
STANDARD_DEVIATION 11.86 • n=279 Participants
|
41.06 years
STANDARD_DEVIATION 12.36 • n=279 Participants
|
40.98 years
STANDARD_DEVIATION 12.11 • n=1117 Participants
|
|
Sex: Female, Male
Female
|
484 Participants
n=559 Participants
|
238 Participants
n=279 Participants
|
228 Participants
n=279 Participants
|
950 Participants
n=1117 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=559 Participants
|
41 Participants
n=279 Participants
|
51 Participants
n=279 Participants
|
167 Participants
n=1117 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
122 Participants
n=559 Participants
|
65 Participants
n=279 Participants
|
69 Participants
n=279 Participants
|
256 Participants
n=1117 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
402 Participants
n=559 Participants
|
196 Participants
n=279 Participants
|
194 Participants
n=279 Participants
|
792 Participants
n=1117 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=559 Participants
|
18 Participants
n=279 Participants
|
16 Participants
n=279 Participants
|
69 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=559 Participants
|
2 Participants
n=279 Participants
|
0 Participants
n=279 Participants
|
6 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=559 Participants
|
13 Participants
n=279 Participants
|
15 Participants
n=279 Participants
|
54 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=559 Participants
|
0 Participants
n=279 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=559 Participants
|
16 Participants
n=279 Participants
|
17 Participants
n=279 Participants
|
72 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
White
|
433 Participants
n=559 Participants
|
224 Participants
n=279 Participants
|
225 Participants
n=279 Participants
|
882 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
More than one race
|
56 Participants
n=559 Participants
|
24 Participants
n=279 Participants
|
21 Participants
n=279 Participants
|
101 Participants
n=1117 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=559 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=279 Participants
|
1 Participants
n=1117 Participants
|
|
Region of Enrollment
Argentina
|
41 Participants
n=559 Participants
|
20 Participants
n=279 Participants
|
21 Participants
n=279 Participants
|
82 Participants
n=1117 Participants
|
|
Region of Enrollment
United States
|
314 Participants
n=559 Participants
|
157 Participants
n=279 Participants
|
158 Participants
n=279 Participants
|
629 Participants
n=1117 Participants
|
|
Region of Enrollment
Czechia
|
25 Participants
n=559 Participants
|
10 Participants
n=279 Participants
|
10 Participants
n=279 Participants
|
45 Participants
n=1117 Participants
|
|
Region of Enrollment
United Kingdom
|
15 Participants
n=559 Participants
|
7 Participants
n=279 Participants
|
9 Participants
n=279 Participants
|
31 Participants
n=1117 Participants
|
|
Region of Enrollment
Spain
|
24 Participants
n=559 Participants
|
14 Participants
n=279 Participants
|
12 Participants
n=279 Participants
|
50 Participants
n=1117 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=559 Participants
|
4 Participants
n=279 Participants
|
3 Participants
n=279 Participants
|
15 Participants
n=1117 Participants
|
|
Region of Enrollment
Netherlands
|
21 Participants
n=559 Participants
|
11 Participants
n=279 Participants
|
11 Participants
n=279 Participants
|
43 Participants
n=1117 Participants
|
|
Region of Enrollment
Taiwan
|
24 Participants
n=559 Participants
|
12 Participants
n=279 Participants
|
12 Participants
n=279 Participants
|
48 Participants
n=1117 Participants
|
|
Region of Enrollment
Italy
|
27 Participants
n=559 Participants
|
14 Participants
n=279 Participants
|
15 Participants
n=279 Participants
|
56 Participants
n=1117 Participants
|
|
Region of Enrollment
Mexico
|
12 Participants
n=559 Participants
|
7 Participants
n=279 Participants
|
5 Participants
n=279 Participants
|
24 Participants
n=1117 Participants
|
|
Region of Enrollment
Israel
|
20 Participants
n=559 Participants
|
10 Participants
n=279 Participants
|
10 Participants
n=279 Participants
|
40 Participants
n=1117 Participants
|
|
Region of Enrollment
Germany
|
28 Participants
n=559 Participants
|
13 Participants
n=279 Participants
|
13 Participants
n=279 Participants
|
54 Participants
n=1117 Participants
|
|
Migraine Headache Days (MHD)
|
19.55 Days per Month
STANDARD_DEVIATION 4.59 • n=558 Participants • All randomized participants who received at least one dose of study drug.
|
19.36 Days per Month
STANDARD_DEVIATION 4.27 • n=278 Participants • All randomized participants who received at least one dose of study drug.
|
19.17 Days per Month
STANDARD_DEVIATION 4.60 • n=277 Participants • All randomized participants who received at least one dose of study drug.
|
19.41 Days per Month
STANDARD_DEVIATION 4.52 • n=1113 Participants • All randomized participants who received at least one dose of study drug.
|
PRIMARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=538 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=273 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=274 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
|
-2.74 Migraine Headache Days per Month
Standard Error 0.36
|
-4.83 Migraine Headache Days per Month
Standard Error 0.44
|
-4.62 Migraine Headache Days per Month
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Outcome measures
| Measure |
Placebo
n=498 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=256 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=262 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
≥50%
|
123 Participants
|
90 Participants
|
97 Participants
|
|
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
≥75%
|
44 Participants
|
34 Participants
|
40 Participants
|
|
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
≥100%
|
8 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \& friends, leisure time, productivity, concentration, energy, tiredness \& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement.
Outcome measures
| Measure |
Placebo
n=494 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=252 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=253 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain
|
16.76 units on a scale
Standard Error 1.18
|
21.81 units on a scale
Standard Error 1.41
|
23.05 units on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=538 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=273 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=274 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
|
-2.23 Days Per Month
Standard Error 0.33
|
-4.74 Days Per Month
Standard Error 0.40
|
-4.25 Days Per Month
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.
PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=494 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=252 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=253 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
|
-0.62 units on a scale
Standard Error 0.08
|
-0.76 units on a scale
Standard Error 0.10
|
-0.91 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline measurement.
Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=538 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=273 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=274 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Headache Hours
|
-13.44 Headache Hours per Month
Standard Error 3.91
|
-36.15 Headache Hours per Month
Standard Error 4.74
|
-31.53 Headache Hours per Month
Standard Error 4.70
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.
Outcome measures
| Measure |
Placebo
n=504 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=254 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=258 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
|
-11.53 units on a scale
Standard Error 3.38
|
-20.27 units on a scale
Standard Error 4.07
|
-17.02 units on a scale
Standard Error 4.05
|
SECONDARY outcome
Timeframe: Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had at least one non-missing test result for ADA for each of the baseline period and the post baseline period.
A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer \>= 20.
Outcome measures
| Measure |
Placebo
n=535 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=264 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=272 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab
|
8 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 3Population: Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3Population: All randomized participants who received at least one dose of study drug and had measurable plasma concentrations.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=247 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
n=253 Participants
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
|
0.529 Nanogram per milliliter (ng/mL)
Standard Deviation 0.612
|
4.02 Nanogram per milliliter (ng/mL)
Standard Deviation 1.70
|
4.85 Nanogram per milliliter (ng/mL)
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Month 3Population: All randomized participants who received at least one dose of Galcanezumab and had measurable serum concentrations.
Serum concentrations of Galcanezumab
Outcome measures
| Measure |
Placebo
n=248 Participants
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg
n=254 Participants
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
|---|---|---|---|
|
Serum Concentrations of Galcanezumab
|
16900 Nanogram per milliliter (ng/mL)
Standard Deviation 7140
|
29000 Nanogram per milliliter (ng/mL)
Standard Deviation 11300
|
—
|
Adverse Events
Placebo - Double-Blind Treatment Phase
Serious events: 5 serious events
Other events: 170 other events
Deaths: 0 deaths
Galcanezumab 120mg - Double-Blind Treatment Phase
Serious events: 2 serious events
Other events: 98 other events
Deaths: 0 deaths
Galcanezumab 240mg - Double-Blind Treatment Phase
Serious events: 4 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo/Galcanezumab - Open-Label Extension Phase
Serious events: 16 serious events
Other events: 223 other events
Deaths: 0 deaths
Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase
Serious events: 6 serious events
Other events: 117 other events
Deaths: 0 deaths
Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase
Serious events: 9 serious events
Other events: 120 other events
Deaths: 0 deaths
Placebo - Follow-up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Galcanezumab 120mg - Follow-up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Galcanezumab 240mg - Follow-up Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo/Galcanezumab - Follow-up Phase
Serious events: 5 serious events
Other events: 57 other events
Deaths: 0 deaths
Galcanezumab 120mg/Galcanezumab - Follow-up Phase
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Galcanezumab 240mg/Galcanezumab - Follow-up Phase
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Israel Addendum
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Double-Blind Treatment Phase
n=558 participants at risk
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=273 participants at risk
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg - Double-Blind Treatment Phase
n=282 participants at risk
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
Placebo/Galcanezumab - Open-Label Extension Phase
n=501 participants at risk
After completion of Placebo double-blind phase, participants had an option to enter open-label extension phase where they received 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase
n=259 participants at risk
After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase
n=262 participants at risk
After completion of Galcanezumab 240mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Placebo - Follow-up Phase
n=15 participants at risk
Participants entered follow-up phase from placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg - Follow-up Phase
n=4 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg - Follow-up Phase
n=4 participants at risk
Participants entered follow-up phase from from Galcanezumab 240mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Placebo/Galcanezumab - Follow-up Phase
n=438 participants at risk
Participants entered follow-up phase from Placebo/Galcanezumabopen-label extension phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg/Galcanezumab - Follow-up Phase
n=223 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg/Galcanezumab - Follow-up Phase
n=228 participants at risk
Participants entered follow-up phase from Galcanezumab 240mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
|
Israel Addendum
n=29 participants at risk
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Congenital diaphragmatic hernia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Swelling face
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant nipple neoplasm
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/483 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/232 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/231 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/433 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/218 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/214 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/376 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/186 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/184 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.21%
1/483 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/232 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/231 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/433 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/218 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/214 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/376 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/186 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/184 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo - Double-Blind Treatment Phase
n=558 participants at risk
Participants received placebo once a month by subcutaneous injection for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=273 participants at risk
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
|
Galcanezumab 240mg - Double-Blind Treatment Phase
n=282 participants at risk
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
|
Placebo/Galcanezumab - Open-Label Extension Phase
n=501 participants at risk
After completion of Placebo double-blind phase, participants had an option to enter open-label extension phase where they received 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase
n=259 participants at risk
After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase
n=262 participants at risk
After completion of Galcanezumab 240mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
|
Placebo - Follow-up Phase
n=15 participants at risk
Participants entered follow-up phase from placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg - Follow-up Phase
n=4 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg - Follow-up Phase
n=4 participants at risk
Participants entered follow-up phase from from Galcanezumab 240mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Placebo/Galcanezumab - Follow-up Phase
n=438 participants at risk
Participants entered follow-up phase from Placebo/Galcanezumabopen-label extension phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg/Galcanezumab - Follow-up Phase
n=223 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 240mg/Galcanezumab - Follow-up Phase
n=228 participants at risk
Participants entered follow-up phase from Galcanezumab 240mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.
|
Israel Addendum
n=29 participants at risk
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
1.1%
6/558 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
6/273 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
7/282 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
7/501 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
8/262 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.68%
3/438 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
2/273 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.00%
5/501 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
2/228 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
2/501 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
22/558 • Number of events 26 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.3%
9/273 • Number of events 12 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
8/282 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
7/501 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/259 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
11/262 • Number of events 12 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
2/228 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Influenza like illness
|
0.54%
3/558 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/273 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
4/282 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.00%
5/501 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.77%
2/259 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.90%
5/558 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/273 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
13/282 • Number of events 16 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
12/501 • Number of events 18 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
6/259 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
10/262 • Number of events 19 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
4.3%
24/558 • Number of events 32 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
18/273 • Number of events 31 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
21/282 • Number of events 33 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
8/501 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/259 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/262 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
1.8%
10/558 • Number of events 16 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
8/273 • Number of events 13 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
15/282 • Number of events 19 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
19/501 • Number of events 51 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.1%
21/259 • Number of events 56 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
17/262 • Number of events 33 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.80%
4/501 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
5/273 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.00%
5/501 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/259 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
3/262 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.54%
3/558 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
5/273 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
14/501 • Number of events 14 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
7/259 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
7/262 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.90%
2/223 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
3/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
2/273 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
8/501 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
7/259 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
2.7%
15/558 • Number of events 16 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
6/282 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
14/501 • Number of events 15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
17/259 • Number of events 21 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
12/262 • Number of events 13 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
5/438 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.90%
2/223 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
4/228 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
24/558 • Number of events 26 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
18/273 • Number of events 20 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
9/282 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.0%
45/501 • Number of events 55 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.3%
24/259 • Number of events 31 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
27/262 • Number of events 32 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
11/438 • Number of events 11 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.90%
2/223 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.2%
5/29 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.90%
5/558 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/273 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.5%
7/282 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
16/501 • Number of events 17 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/259 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
10/262 • Number of events 11 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
7/438 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
14/558 • Number of events 14 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
8/273 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
9/282 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
27/501 • Number of events 31 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
17/259 • Number of events 21 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
18/262 • Number of events 23 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.91%
4/438 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.90%
2/223 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
3/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
6/558 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
6/273 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
5/282 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
29/501 • Number of events 33 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
6/259 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/262 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
9/438 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
3/223 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
3/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
8/558 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
2/273 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
5/282 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
25/501 • Number of events 28 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/259 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
7/262 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
7/438 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
14/558 • Number of events 15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
8/273 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
11/501 • Number of events 12 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
13/259 • Number of events 13 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
13/262 • Number of events 13 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
4/223 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
7/558 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
7/273 • Number of events 8 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
3/501 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
6/259 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
12/262 • Number of events 13 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
5/438 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.90%
5/558 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
3/273 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/282 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
10/501 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.77%
2/259 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/262 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
3/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.20%
1/501 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
3.4%
19/558 • Number of events 20 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
6/273 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
9/282 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
10/501 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/259 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
7/262 • Number of events 11 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
2/228 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
1.4%
8/558 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/273 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
7/501 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/259 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.36%
2/558 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.80%
4/501 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
2/501 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep disorder
|
0.18%
1/558 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.37%
1/273 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.54%
3/558 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/273 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
4/282 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
8/501 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/259 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
9/262 • Number of events 9 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.68%
3/438 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
2/29 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.54%
3/558 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
2/273 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
4/282 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
8/501 • Number of events 10 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
5/259 • Number of events 5 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/262 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.45%
1/223 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.7%
6/29 • Number of events 7 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/558 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/501 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/262 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/438 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/29 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
2/558 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/273 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.35%
1/282 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.00%
5/501 • Number of events 6 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
4/259 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.76%
2/262 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.23%
1/438 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/228 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.8%
4/29 • Number of events 4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.54%
3/558 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.73%
2/273 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/282 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
8/501 • Number of events 11 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.77%
2/259 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.38%
1/262 • Number of events 1 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.46%
2/438 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/223 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.44%
1/228 • Number of events 2 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
3/29 • Number of events 3 • Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.
All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place