Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (NCT NCT03725202)
NCT ID: NCT03725202
Last Updated: 2025-03-27
Results Overview
Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
438 participants
Primary outcome timeframe
From Week 12 to Week 52
Results posted on
2025-03-27
Participant Flow
This trial was conducted at 100 sites in 23 countries. Participants were randomized via in a 2:1:1 ratio to receive either upadacitinib 15 mg or 7.5 mg once daily in combination with a predefined 26-week CS taper regimen, or placebo with a predefined 52-week CS taper regimen
Those assigned to upadacitinib who achieved sustained remission for at least 24 consecutive weeks prior to Week 52 visit (at the end of Period 1) were re-randomized in a 2:1 ratio to either stay on upadacitinib or switch to placebo in Period 2. Those on placebo who achieved sustained remission for at least 24 weeks prior to Week 52 visit continued on placebo in Period 2.
Participant milestones
| Measure |
Placebo + 52-week CS Taper
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
Placebo + 52-week CS Taper -> Placebo
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1 (Baseline - Week 52)
STARTED
|
112
|
107
|
210
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Randomized
|
112
|
107
|
210
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Received Randomized Study Drug
|
112
|
107
|
209
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
COMPLETED
|
86
|
85
|
177
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
NOT COMPLETED
|
26
|
22
|
33
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Week 52 - Week 104)
STARTED
|
0
|
0
|
0
|
43
|
39
|
14
|
92
|
35
|
|
Period 2 (Week 52 - Week 104)
COMPLETED
|
0
|
0
|
0
|
20
|
27
|
9
|
58
|
22
|
|
Period 2 (Week 52 - Week 104)
NOT COMPLETED
|
0
|
0
|
0
|
23
|
12
|
5
|
34
|
13
|
Reasons for withdrawal
| Measure |
Placebo + 52-week CS Taper
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
Placebo + 52-week CS Taper -> Placebo
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> Placebo
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1 (Baseline - Week 52)
Adverse Event
|
13
|
11
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Withdrew consent
|
5
|
6
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
COVID-19 logistical restrictions
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Failure to meet continuation criteria
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Other, not specified
|
5
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Baseline - Week 52)
Did not receive randomized study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Week 52 - Week 104)
Ongoing in Period 2
|
0
|
0
|
0
|
19
|
11
|
2
|
27
|
8
|
|
Period 2 (Week 52 - Week 104)
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
2
|
4
|
2
|
|
Period 2 (Week 52 - Week 104)
Withdrew consent
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
|
Period 2 (Week 52 - Week 104)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 (Week 52 - Week 104)
Failure to meet continuation criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 2 (Week 52 - Week 104)
Other, not specified
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Baseline characteristics by cohort
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 7.33 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 7.55 • n=7 Participants
|
70.8 years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 7.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
415 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
401 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Week 12 to Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Remission at Week 52
|
29.0 percentage of participants
Interval 20.6 to 37.5
|
41.1 percentage of participants
Interval 31.8 to 50.4
|
46.4 percentage of participants
Interval 39.6 to 53.2
|
SECONDARY outcome
Timeframe: Week 12 through Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; normalization of erythrocyte sedimentation rate (ESR); normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
|
16.1 percentage of participants
Interval 9.3 to 22.9
|
26.2 percentage of participants
Interval 17.8 to 34.5
|
37.1 percentage of participants
Interval 30.5 to 43.7
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1. As observed analysis; participants who did not have an evaluation on a scheduled visit were excluded from the analysis for that visit.
The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=90 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=86 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=180 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Cumulative Corticosteroid (CS) Exposure Through Week 52
|
2882.0 mg
Interval 2762.0 to 3253.0
|
1905.0 mg
Interval 1615.0 to 2265.0
|
1615.0 mg
Interval 1615.0 to 1635.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1
Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Time to First Disease Flare Through Week 52
|
323.0 days
Interval 249.0 to
Not calculable/estimable due to low number of participants with events
|
NA days
Interval 316.0 to
Not calculable/estimable due to low number of participants with events
|
NA days
Not calculable/estimable due to low number of participants with events
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis
The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
|
55.6 percentage of participants
Interval 42.9 to 69.2
|
41.3 percentage of participants
Interval 32.2 to 51.7
|
34.3 percentage of participants
Interval 27.4 to 42.4
|
SECONDARY outcome
Timeframe: At Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Percentage of Participants in Complete Remission at Week 52
|
19.6 percentage of participants
Interval 12.3 to 27.0
|
43.0 percentage of participants
Interval 33.6 to 52.4
|
50.2 percentage of participants
Interval 43.4 to 57.1
|
SECONDARY outcome
Timeframe: At Week 24Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used.
Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Percentage of Participants in Complete Remission at Week 24
|
36.1 percentage of participants
Interval 27.2 to 45.1
|
39.3 percentage of participants
Interval 30.0 to 48.5
|
57.2 percentage of participants
Interval 50.5 to 64.0
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=44 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=49 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=123 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
|
-1.2892 units on a scale
Interval -3.3093 to 0.7309
|
1.3202 units on a scale
Interval -0.6553 to 3.2957
|
2.4634 units on a scale
Interval 1.1707 to 3.7561
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis
The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Number of Disease Flares Per Participant Through Week 52
|
0.7 Disease Flare per Participant per Year
Interval 0.5 to 0.9
|
0.6 Disease Flare per Participant per Year
Interval 0.4 to 0.7
|
0.4 Disease Flare per Participant per Year
Interval 0.3 to 0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=45 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=49 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=123 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
|
-2.4 units on a scale
Interval -4.71 to -0.07
|
1.1 units on a scale
Interval -1.17 to 3.37
|
1.7 units on a scale
Interval 0.18 to 3.14
|
SECONDARY outcome
Timeframe: At Week 52Population: Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values
The Treatment Satisfaction Questionnaire for Medications (TSQM) is a generic ePRO measure of treatment satisfaction, developed to compare treatment satisfaction between medication types and conditions. TSQM comprises of 14 items to assess 4 domains (effectiveness, side effects, convenience, and global satisfaction). The TSQM items are rated on a Likert scale (1 = extremely dissatisfied to 7 = extremely satisfied). Scores for each of the 4 domains range from 0 to 100, with higher scores corresponding to higher satisfaction. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=45 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=52 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=126 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
|
68.8428 units on a scale
Interval 63.831 to 73.8547
|
74.2644 units on a scale
Interval 69.4483 to 79.0805
|
71.5753 units on a scale
Interval 68.3375 to 74.8131
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety Analysis Set in Period 1: all participants who received at least 1 dose of study drug in Period 1
The rate of corticosteroid-related adverse events was calculated, and was adjusted by duration of study drug exposure.
Outcome measures
| Measure |
Placebo + 52-week CS Taper
n=112 Participants
Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 Participants
Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=209 Participants
Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
|---|---|---|---|
|
Rate of Corticosteroid-related Adverse Events Though Week 52
|
1.7 CS-related AE per participant per year
Interval 1.3 to 2.3
|
1.7 CS-related AE per participant per year
Interval 1.2 to 2.2
|
2.0 CS-related AE per participant per year
Interval 1.7 to 2.4
|
Adverse Events
Placebo + 52-week CS Taper
Serious events: 24 serious events
Other events: 88 other events
Deaths: 2 deaths
7.5 mg Upadacitinib + 26-week CS Taper
Serious events: 14 serious events
Other events: 88 other events
Deaths: 0 deaths
15 mg Upadacitinib + 26-week CS Taper
Serious events: 50 serious events
Other events: 174 other events
Deaths: 3 deaths
Placebo + 52-week CS Taper -> Placebo
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
7.5 mg Upadacitinib + 26-week CS Taper -> Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib
Serious events: 11 serious events
Other events: 61 other events
Deaths: 0 deaths
15 mg Upadacitinib + 26-week CS Taper -> Placebo
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + 52-week CS Taper
n=112 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 participants at risk
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=210 participants at risk
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
Placebo + 52-week CS Taper -> Placebo
n=43 participants at risk
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib
n=39 participants at risk
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> Placebo
n=14 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib
n=92 participants at risk
Participants randomized to receive15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> Placebo
n=35 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
ENDOCARDITIS FIBROPLASTICA
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Endocrine disorders
TOXIC NODULAR GOITRE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Eye disorders
MACULAR OEDEMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
GASTROINTESTINAL ANGIODYSPLASIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
1.8%
2/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
DEATH
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
FATIGUE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
ASPERGILLUS INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
COVID-19
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
GASTROENTERITIS CLOSTRIDIAL
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
GENITOURINARY TRACT INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
OPHTHALMIC HERPES ZOSTER
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.4%
3/210 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
PNEUMONIA
|
4.5%
5/112 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
PSEUDOMONAL BACTERAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
SEPSIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
SEPTIC ARTHRITIS STREPTOCOCCAL
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
UROSEPSIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
WOUND INFECTION
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
FALL
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
TROPONIN T INCREASED
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.9%
2/107 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
MENISCAL DEGENERATION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF AMPULLA OF VATER
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYXOMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATIC ADENOMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONSIL CANCER METASTATIC
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
CEREBELLAR ATAXIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
CEREBRAL AMYLOID ANGIOPATHY
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
CEREBROSPINAL FISTULA
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
QUADRANTANOPIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
SYNCOPE
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Psychiatric disorders
SUBSTANCE-INDUCED PSYCHOTIC DISORDER
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.4%
5/210 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.4%
3/210 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
GIANT CELL ARTERITIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.9%
4/210 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
Other adverse events
| Measure |
Placebo + 52-week CS Taper
n=112 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
|
7.5 mg Upadacitinib + 26-week CS Taper
n=107 participants at risk
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
15 mg Upadacitinib + 26-week CS Taper
n=210 participants at risk
Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
|
Placebo + 52-week CS Taper -> Placebo
n=43 participants at risk
Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib
n=39 participants at risk
Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
7.5 mg Upadacitinib + 26-week CS Taper -> Placebo
n=14 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib
n=92 participants at risk
Participants randomized to receive15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
|
15 mg Upadacitinib + 26-week CS Taper -> Placebo
n=35 participants at risk
Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
CATARACT
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.8%
10/210 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.0%
3/43 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.5%
5/112 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.5%
8/107 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.7%
12/112 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
5/107 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.1%
17/210 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.1%
2/39 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
3/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Gastrointestinal disorders
NAUSEA
|
3.6%
4/112 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
FATIGUE
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.7%
4/107 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
18/210 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
MALAISE
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.4%
5/210 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
OEDEMA PERIPHERAL
|
1.8%
2/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.5%
7/107 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
15/210 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
General disorders
PERIPHERAL SWELLING
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.4%
5/210 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
BRONCHITIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.8%
8/210 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
COVID-19
|
10.7%
12/112 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
11.2%
12/107 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
12.9%
27/210 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
16.3%
7/43 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
15.4%
6/39 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
16.3%
15/92 • Number of events 15 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
17.1%
6/35 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
CYSTITIS
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
5/107 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.7%
14/210 • Number of events 19 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
INFLUENZA
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.9%
4/210 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.6%
13/112 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
18/210 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
10.3%
4/39 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.5%
6/92 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
3/35 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.4%
3/210 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.1%
2/39 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
SINUSITIS
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.9%
2/107 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.4%
3/210 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
3/92 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
3/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
TOOTH INFECTION
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.1%
8/112 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.5%
8/107 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
14.3%
2/14 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
15.2%
17/112 • Number of events 26 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
14.0%
15/107 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
10.0%
21/210 • Number of events 25 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.7%
3/39 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
5/107 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
7/210 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.1%
2/39 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
FALL
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.7%
4/107 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
7/210 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
3/92 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
GLUCOSE URINE PRESENT
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
OCCULT BLOOD POSITIVE
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Investigations
WEIGHT INCREASED
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
6/210 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.1%
2/39 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
3/92 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.4%
15/112 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.5%
7/107 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
13.8%
29/210 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
18.6%
8/43 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
10.9%
10/92 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
3/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.5%
14/112 • Number of events 15 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
11.9%
25/210 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.4%
5/92 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
3/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
GREATER TROCHANTERIC PAIN SYNDROME
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.9%
2/107 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.1%
8/112 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.2%
13/210 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.5%
5/112 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.5%
7/107 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
9/210 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.6%
3/35 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.4%
3/210 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.3%
4/92 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.7%
4/107 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
15/210 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.5%
6/92 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
2.7%
3/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
DIZZINESS
|
5.4%
6/112 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.6%
6/107 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.8%
10/210 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
1.1%
1/92 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Nervous system disorders
HEADACHE
|
11.6%
13/112 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
15.0%
16/107 • Number of events 23 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
15.7%
33/210 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.7%
3/39 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
12.0%
11/92 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.48%
1/210 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.6%
4/112 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
4.7%
5/107 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
6.7%
14/210 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.2%
2/92 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.9%
1/35 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.4%
5/210 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/112 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.8%
2/112 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/107 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.95%
2/210 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.7%
2/35 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.7%
3/112 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.8%
3/107 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.2%
11/210 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
3.3%
3/92 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.89%
1/112 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.93%
1/107 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/210 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/43 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/39 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/92 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/35 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
GIANT CELL ARTERITIS
|
30.4%
34/112 • Number of events 41 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
25.2%
27/107 • Number of events 34 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
21.4%
45/210 • Number of events 57 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
16.3%
7/43 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.1%
2/39 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
28.6%
4/14 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
8.7%
8/92 • Number of events 8 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
37.1%
13/35 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
|
Vascular disorders
HYPERTENSION
|
11.6%
13/112 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
15.0%
16/107 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
13.3%
28/210 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
2.6%
1/39 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
0.00%
0/14 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
5.4%
5/92 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
14.3%
5/35 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
|
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