Trial Outcomes & Findings for Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (NCT NCT03271489)
NCT ID: NCT03271489
Last Updated: 2025-07-22
Results Overview
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
Baseline to 60 months
Results posted on
2025-07-22
Participant Flow
A total of 478 participants were enrolled across the United States and Puerto Rico.
Participant milestones
| Measure |
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)
Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up
|
Placebo
Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up
|
|---|---|---|
|
Screening Period
STARTED
|
319
|
159
|
|
Screening Period
COMPLETED
|
319
|
159
|
|
Screening Period
NOT COMPLETED
|
0
|
0
|
|
Double-Blind (DB) Period
STARTED
|
319
|
159
|
|
Double-Blind (DB) Period
COMPLETED
|
283
|
135
|
|
Double-Blind (DB) Period
NOT COMPLETED
|
36
|
24
|
|
Open-Label (OL) Period
STARTED
|
193
|
84
|
|
Open-Label (OL) Period
COMPLETED
|
159
|
68
|
|
Open-Label (OL) Period
NOT COMPLETED
|
34
|
16
|
|
Post-Treatment Follow-Up (PTFU) Period
STARTED
|
319
|
159
|
|
Post-Treatment Follow-Up (PTFU) Period
COMPLETED
|
189
|
86
|
|
Post-Treatment Follow-Up (PTFU) Period
NOT COMPLETED
|
130
|
73
|
Reasons for withdrawal
| Measure |
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)
Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up
|
Placebo
Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up
|
|---|---|---|
|
Double-Blind (DB) Period
Adverse Event
|
4
|
1
|
|
Double-Blind (DB) Period
Withdrawal by Subject
|
13
|
10
|
|
Double-Blind (DB) Period
Lost to Follow-up
|
9
|
9
|
|
Double-Blind (DB) Period
Requires surgery or invasive intervention for treatment of uterine fibroids
|
3
|
2
|
|
Double-Blind (DB) Period
Non-compliance with study procedures
|
0
|
1
|
|
Double-Blind (DB) Period
Other
|
6
|
1
|
|
Double-Blind (DB) Period
Missing
|
1
|
0
|
|
Open-Label (OL) Period
Adverse Event
|
2
|
0
|
|
Open-Label (OL) Period
Withdrawal by Subject
|
14
|
8
|
|
Open-Label (OL) Period
Lost to Follow-up
|
10
|
5
|
|
Open-Label (OL) Period
Non-compliance with study procedures
|
4
|
1
|
|
Open-Label (OL) Period
No Specified
|
2
|
2
|
|
Open-Label (OL) Period
Missing
|
2
|
0
|
|
Post-Treatment Follow-Up (PTFU) Period
Adverse Event
|
16
|
6
|
|
Post-Treatment Follow-Up (PTFU) Period
Withdrawal by Subject
|
40
|
26
|
|
Post-Treatment Follow-Up (PTFU) Period
Lost to Follow-up
|
35
|
24
|
|
Post-Treatment Follow-Up (PTFU) Period
Requires surgery or invasive intervention for treatment of uterine fibroids
|
5
|
3
|
|
Post-Treatment Follow-Up (PTFU) Period
Non-compliance with study procedures
|
9
|
2
|
|
Post-Treatment Follow-Up (PTFU) Period
COVID-19 logistical restrictions
|
1
|
0
|
|
Post-Treatment Follow-Up (PTFU) Period
Other
|
21
|
10
|
|
Post-Treatment Follow-Up (PTFU) Period
Missing
|
3
|
2
|
Baseline Characteristics
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Baseline characteristics by cohort
| Measure |
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)
n=319 Participants
Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up
|
Placebo
n=159 Participants
Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 Years
STANDARD_DEVIATION 5.07 • n=99 Participants
|
41.7 Years
STANDARD_DEVIATION 5.65 • n=107 Participants
|
42.3 Years
STANDARD_DEVIATION 5.28 • n=206 Participants
|
|
Sex: Female, Male
Female
|
319 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
242 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
171 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 60 monthsPopulation: Safety Analysis Set
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Outcome measures
| Measure |
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)
n=319 Participants
Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up.
|
Placebo
n=159 Participants
Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Double-blind Period
|
203 Participants
|
83 Participants
|
|
Number of Participants With Adverse Events (AEs)
Open-label Period
|
124 Participants
|
59 Participants
|
|
Number of Participants With Adverse Events (AEs)
Post-treatment Follow-up Period
|
22 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 60Population: Of the total participants in the Safety Analysis Set, each row includes participants with a BMD decrease from baseline at their final on-treatment visit (up to Month 48), in any location (spine, total hip or femoral neck), and at least 1 DXA scan during the follow-up period.
Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100\*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.
Outcome measures
| Measure |
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)
n=111 Participants
Participants were randomized to receive elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 48 months followed by 12 months post-treatment follow-up.
|
Placebo
n=40 Participants
Participants were randomized to receive placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA (estradiol 1 mg/norethindrone acetate 0.5 mg QD) for 36 months followed by 12 months post-treatment follow-up.
|
|---|---|---|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · < 0% Recovery
|
24 Participants
|
10 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · 0% - 25% Recovery
|
8 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · > 25% - 50% Recovery
|
3 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · > 50% - 75% Recovery
|
5 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · > 75% - 100% Recovery
|
5 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (6 months PTFU) · > 100% Recovery
|
9 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · < 0% Recovery
|
23 Participants
|
10 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · > 25% - 50% Recovery
|
5 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · > 50% - 75% Recovery
|
9 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · > 75% - 100% Recovery
|
5 Participants
|
0 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · > 100% Recovery
|
20 Participants
|
7 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · < 0% Recovery
|
20 Participants
|
10 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · 0% - 25% Recovery
|
5 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · > 25% - 50% Recovery
|
5 Participants
|
4 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · > 50% - 75% Recovery
|
7 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · > 75% - 100% Recovery
|
1 Participants
|
0 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (6 months PTFU) · > 100% Recovery
|
13 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · < 0% Recovery
|
22 Participants
|
12 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · 0% - 25% Recovery
|
11 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · > 25% - 50% Recovery
|
7 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · > 50% - 75% Recovery
|
6 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · > 75% - 100% Recovery
|
5 Participants
|
0 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · 0% - 25% Recovery
|
5 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · > 25% - 50% Recovery
|
8 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · > 50% - 75% Recovery
|
5 Participants
|
4 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · > 75% - 100% Recovery
|
4 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · > 100% Recovery
|
7 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · < 0% Recovery
|
18 Participants
|
10 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · 0% - 25% Recovery
|
12 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · > 25% - 50% Recovery
|
7 Participants
|
1 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · > 50% - 75% Recovery
|
6 Participants
|
3 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · > 100% Recovery
|
14 Participants
|
5 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Spine (12 months PTFU) · 0% - 25% Recovery
|
3 Participants
|
2 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Total Hip (12 months PTFU) · > 100% Recovery
|
15 Participants
|
3 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (6 months PTFU) · < 0% Recovery
|
22 Participants
|
10 Participants
|
|
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Femoral Neck (12 months PTFU) · > 75% - 100% Recovery
|
3 Participants
|
1 Participants
|
Adverse Events
Screening Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Screening Elagolix E2/NETA
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Double-Blind Placebo
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Double-Blind Elagolix E2/NETA
Serious events: 10 serious events
Other events: 88 other events
Deaths: 1 deaths
Open Label Placebo to Elagolix E2/NETA
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Open Label Elagolix E2 NETA to Elagolix E2/NETA
Serious events: 9 serious events
Other events: 65 other events
Deaths: 0 deaths
Follow-up: Placebo to Elagolix E2/NETA
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Follow-up: Elagolix E2 NETA to Elagolix E2/NETA
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Screening Placebo
n=159 participants at risk
AEs and SAEs during the screening period were collected from the time of informed consent to the first dose of placebo (approximately 2.5 to 5 months).
|
Screening Elagolix E2/NETA
n=319 participants at risk
AEs and SAEs during the screening period were collected from the time of informed consent to the first dose of Elagolix E2/NETA (approximately 2.5 to 5 months).
|
Double-Blind Placebo
n=159 participants at risk
Participants received 12 months of treatment with placebo. AEs and SAEs during the Double-Blind treatment period were collected from the first dose of placebo to the start of the open label period (12 months).
|
Double-Blind Elagolix E2/NETA
n=319 participants at risk
Participants received 12 months of treatment with elagolix 300 mg BID plus E2/NETA. AEs and SAEs during the Double-Blind treatment period were collected from the first dose of study drug to the start of the open label period (12 months).
|
Open Label Placebo to Elagolix E2/NETA
n=84 participants at risk
For months 13 through 48, participants randomized to placebo in the 12-month double-blind treatment period switched to elagolix 300 mg BID plus E2/NETA during the open label treatment period. AEs and SAEs during the open label treatment period were collected from the first dose of open label study drug to the end of treatment.
|
Open Label Elagolix E2 NETA to Elagolix E2/NETA
n=193 participants at risk
For months 13 through 48, participants randomized to Double-Blind Elagolix E2/NETA in the 12-month double-blind treatment period continued receiving elagolix 300 mg BID plus E2/NETA during the open label treatment period. AEs and SAEs during the open label treatment period were collected from the first dose of open label study drug to the end of treatment.
|
Follow-up: Placebo to Elagolix E2/NETA
n=159 participants at risk
Participants entered the 12-month PTFU period after the last dose of study drug (after completing treatment month 48 or at any time a participant prematurely discontinued during the treatment period). AEs and SAEs were collected from the end of treatment through the end of the PTFU period. Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
Follow-up: Elagolix E2 NETA to Elagolix E2/NETA
n=319 participants at risk
Participants entered the 12-month PTFU period after the last dose of study drug (after completing treatment month 48 or at any time a participant prematurely discontinued during the treatment period). AEs and SAEs were collected from the end of treatment through the end of the PTFU period. Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.3%
2/159 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
2.4%
2/84 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Endocrine disorders
THYROID MASS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Gastrointestinal disorders
HAEMOPERITONEUM
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
General disorders
DEATH
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
General disorders
PAIN
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
General disorders
PROLAPSE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
2/319 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.2%
1/84 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/84 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
Other adverse events
| Measure |
Screening Placebo
n=159 participants at risk
AEs and SAEs during the screening period were collected from the time of informed consent to the first dose of placebo (approximately 2.5 to 5 months).
|
Screening Elagolix E2/NETA
n=319 participants at risk
AEs and SAEs during the screening period were collected from the time of informed consent to the first dose of Elagolix E2/NETA (approximately 2.5 to 5 months).
|
Double-Blind Placebo
n=159 participants at risk
Participants received 12 months of treatment with placebo. AEs and SAEs during the Double-Blind treatment period were collected from the first dose of placebo to the start of the open label period (12 months).
|
Double-Blind Elagolix E2/NETA
n=319 participants at risk
Participants received 12 months of treatment with elagolix 300 mg BID plus E2/NETA. AEs and SAEs during the Double-Blind treatment period were collected from the first dose of study drug to the start of the open label period (12 months).
|
Open Label Placebo to Elagolix E2/NETA
n=84 participants at risk
For months 13 through 48, participants randomized to placebo in the 12-month double-blind treatment period switched to elagolix 300 mg BID plus E2/NETA during the open label treatment period. AEs and SAEs during the open label treatment period were collected from the first dose of open label study drug to the end of treatment.
|
Open Label Elagolix E2 NETA to Elagolix E2/NETA
n=193 participants at risk
For months 13 through 48, participants randomized to Double-Blind Elagolix E2/NETA in the 12-month double-blind treatment period continued receiving elagolix 300 mg BID plus E2/NETA during the open label treatment period. AEs and SAEs during the open label treatment period were collected from the first dose of open label study drug to the end of treatment.
|
Follow-up: Placebo to Elagolix E2/NETA
n=159 participants at risk
Participants entered the 12-month PTFU period after the last dose of study drug (after completing treatment month 48 or at any time a participant prematurely discontinued during the treatment period). AEs and SAEs were collected from the end of treatment through the end of the PTFU period. Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
Follow-up: Elagolix E2 NETA to Elagolix E2/NETA
n=319 participants at risk
Participants entered the 12-month PTFU period after the last dose of study drug (after completing treatment month 48 or at any time a participant prematurely discontinued during the treatment period). AEs and SAEs were collected from the end of treatment through the end of the PTFU period. Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
13.1%
11/84 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
12.4%
24/193 • Number of events 27 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Infections and infestations
TRICHOMONIASIS
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
2/319 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
6.0%
5/84 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/193 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Investigations
BONE DENSITY DECREASED
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.3%
2/159 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
5.0%
16/319 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
9.5%
8/84 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
14.0%
27/193 • Number of events 27 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.9%
3/159 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
2.8%
9/319 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
7.1%
6/84 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
2.1%
4/193 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
5.0%
8/159 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.8%
12/319 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.6%
3/84 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.52%
1/193 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.8%
6/159 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
5.3%
17/319 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
4.8%
4/84 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.6%
3/193 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
2.5%
4/159 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.9%
6/319 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
8.3%
7/84 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.6%
3/193 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
2/319 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.6%
5/319 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
4.8%
4/84 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
5.7%
11/193 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.63%
1/159 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.8%
6/159 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
9.4%
30/319 • Number of events 34 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
7.1%
6/84 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
1.6%
3/193 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.31%
1/319 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.1%
5/159 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
2.8%
9/319 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
6.0%
5/84 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
3.6%
7/193 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/159 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
0.00%
0/319 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).
Safety reporting during the PTFU period included Adverse Events of Special Interest (AESIs). Other AEs may have also been reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER