Trial Outcomes & Findings for Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo (NCT NCT04927975)
NCT ID: NCT04927975
Last Updated: 2024-10-08
Results Overview
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2024-10-08
Participant Flow
ITT Population in Period 1 (ITT\_1): all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to. Per protocol, participants who were randomized to Placebo at Baseline were analyzed as one group in Period 1. ITT Population in Period 2 (ITT\_2): all participants who entered Period 2, analyzed according to the treatment groups that they were randomized to at Baseline.
Participant milestones
| Measure |
Placebo Period 1
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Placebo Period 1, Then Upa 11 mg Period 2
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Placebo Period 1, Then Upa 22 mg Period 2
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|---|---|
|
Period 1 (Baseline-Week 24)
STARTED
|
46
|
0
|
0
|
49
|
47
|
43
|
|
Period 1 (Baseline-Week 24)
COMPLETED
|
44
|
0
|
0
|
46
|
45
|
38
|
|
Period 1 (Baseline-Week 24)
NOT COMPLETED
|
2
|
0
|
0
|
3
|
2
|
5
|
|
Period 2 (Week 24-52)
STARTED
|
0
|
21
|
22
|
45
|
45
|
33
|
|
Period 2 (Week 24-52)
COMPLETED
|
0
|
19
|
21
|
39
|
38
|
30
|
|
Period 2 (Week 24-52)
NOT COMPLETED
|
0
|
2
|
1
|
6
|
7
|
3
|
Reasons for withdrawal
| Measure |
Placebo Period 1
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Placebo Period 1, Then Upa 11 mg Period 2
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Placebo Period 1, Then Upa 22 mg Period 2
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|---|---|
|
Period 1 (Baseline-Week 24)
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
1
|
4
|
|
Period 1 (Baseline-Week 24)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Period 1 (Baseline-Week 24)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 (Week 24-52)
Lost to Follow-up
|
0
|
1
|
0
|
2
|
6
|
2
|
|
Period 2 (Week 24-52)
Withdrawal by Subject
|
0
|
1
|
1
|
4
|
1
|
1
|
Baseline Characteristics
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo
Baseline characteristics by cohort
| Measure |
Placebo Period 1
n=46 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=49 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=47 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=43 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 11.13 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 11.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
165 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 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
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Total Vitiligo Area Scoring Index (T-VASI)
|
21.014 units on a scale
STANDARD_DEVIATION 16.9516 • n=5 Participants
|
20.993 units on a scale
STANDARD_DEVIATION 15.9672 • n=7 Participants
|
22.322 units on a scale
STANDARD_DEVIATION 18.1784 • n=5 Participants
|
21.843 units on a scale
STANDARD_DEVIATION 15.9324 • n=4 Participants
|
21.534 units on a scale
STANDARD_DEVIATION 16.6634 • n=21 Participants
|
|
Facial Vitiligo Area Scoring Index (F-VASI)
|
1.043 units on a scale
STANDARD_DEVIATION 0.6094 • n=5 Participants
|
1.154 units on a scale
STANDARD_DEVIATION 0.7655 • n=7 Participants
|
1.021 units on a scale
STANDARD_DEVIATION 0.5781 • n=5 Participants
|
1.159 units on a scale
STANDARD_DEVIATION 0.6585 • n=4 Participants
|
1.094 units on a scale
STANDARD_DEVIATION 0.6559 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Placebo Period 1
n=43 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=45 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=43 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=33 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24
|
-14.36 Percent change from baseline
Interval -24.86 to -3.85
|
-21.96 Percent change from baseline
Interval -32.18 to -11.75
|
-35.63 Percent change from baseline
Interval -46.11 to -25.14
|
-33.96 Percent change from baseline
Interval -45.41 to -22.5
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo Period 1
n=46 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=49 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=47 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=43 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) at Week 24
|
2.2 percentage of participants
Interval 0.0 to 6.4
|
8.2 percentage of participants
Interval 0.5 to 15.8
|
19.1 percentage of participants
Interval 7.9 to 30.4
|
14.0 percentage of participants
Interval 3.6 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo Period 1
n=46 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=49 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=47 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=43 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) at Week 24
|
10.9 percentage of participants
Interval 1.9 to 19.9
|
16.3 percentage of participants
Interval 6.0 to 26.7
|
38.3 percentage of participants
Interval 24.4 to 52.2
|
39.5 percentage of participants
Interval 24.9 to 54.1
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; NRI-MI (non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo Period 1
n=46 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=49 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=47 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=43 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) at Week 24
|
2.2 percentage of participants
Interval 0.0 to 6.4
|
6.1 percentage of participants
Interval 0.0 to 12.8
|
6.4 percentage of participants
Interval 0.0 to 13.4
|
11.6 percentage of participants
Interval 2.0 to 21.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits.
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Placebo Period 1
n=43 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=45 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=43 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=33 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Percent Change From Baseline in T-VASI at Week 24
|
-6.42 Percent change from baseline
Interval -13.17 to 0.34
|
-13.87 Percent change from baseline
Interval -20.45 to -7.29
|
-17.26 Percent change from baseline
Interval -24.0 to -10.52
|
-20.69 Percent change from baseline
Interval -28.05 to -13.32
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT\_1: all randomized participants in Period 1, analyzed according to the treatment groups that they were randomized to; mixed model repeated measures analysis (MMRM) including observed measurements at all visits.
The VitiQoL is a validated questionnaire used in clinical trials to assess stigma-related vitiligo impacts. The VitiQoL uses subject-elicited social, affective, and behavior items, asking the subject's appraisal of the vitiligo-related impacts over the last month. Fifteen items are scored on a 7-point scale ranging from 0 ("Not at all") to 6 ("All of the time"). Item scores (0 to 6) are summed to provide a total score range of 0 to 90; higher scores indicate greater impairment of quality of life (QoL). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Placebo Period 1
n=40 Participants
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=44 Participants
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=44 Participants
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=34 Participants
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in the Vitiligo Quality-of-Life (VitiQoL) Instrument Total Score at Week 24
|
-5.5 units on a scale
Interval -10.3 to -0.8
|
-7.5 units on a scale
Interval -12.0 to -3.0
|
-3.7 units on a scale
Interval -8.2 to 0.9
|
-6.6 units on a scale
Interval -11.6 to -1.6
|
Adverse Events
Placebo Period 1
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Upa 6 mg Period 1
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Upa 11 mg Period 1
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Upa 22 mg Period 1
Serious events: 3 serious events
Other events: 23 other events
Deaths: 1 deaths
Placebo Period 1, Then Upa 11 mg Period 2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Period 1, Then Upa 22 mg Period 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Upa 6 mg Period 1, Then Upa 6 mg Period 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Upa 11 mg Period 1, Then Upa 11 mg Period 2
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Upa 22 mg Period 1, Then Upa 22 mg Period 2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Period 1
n=46 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 6 mg Period 1
n=49 participants at risk
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 11 mg Period 1
n=47 participants at risk
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 22 mg Period 1
n=43 participants at risk
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Placebo Period 1, Then Upa 11 mg Period 2
n=21 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Placebo Period 1, Then Upa 22 mg Period 2
n=22 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=45 participants at risk
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=45 participants at risk
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=33 participants at risk
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.0%
1/49 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
General disorders
DEATH
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
General disorders
PAIN
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.8%
1/21 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE LOBULAR BREAST CARCINOMA
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
Other adverse events
| Measure |
Placebo Period 1
n=46 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 6 mg Period 1
n=49 participants at risk
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 11 mg Period 1
n=47 participants at risk
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Upa 22 mg Period 1
n=43 participants at risk
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. AEs and SAEs were collected from the time of informed consent and during Period 1, as long as it did not exceed the start date of Period 2.
|
Placebo Period 1, Then Upa 11 mg Period 2
n=21 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Placebo Period 1, Then Upa 22 mg Period 2
n=22 participants at risk
Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 6 mg Period 1, Then Upa 6 mg Period 2
n=45 participants at risk
Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 11 mg Period 1, Then Upa 11 mg Period 2
n=45 participants at risk
Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
Upa 22 mg Period 1, Then Upa 22 mg Period 2
n=33 participants at risk
Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2. AEs and SAEs were collected from the start date of Period 2 to the end of the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.5%
1/22 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
2/33 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.7%
4/46 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.4%
3/47 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.8%
1/21 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Gastrointestinal disorders
NAUSEA
|
6.5%
3/46 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.3%
2/47 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.3%
4/43 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.0%
1/49 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.3%
2/47 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
7.0%
3/43 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
3.0%
1/33 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
General disorders
FATIGUE
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.1%
2/49 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.3%
2/47 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
11.6%
5/43 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.8%
1/21 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.4%
2/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.5%
3/46 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.0%
1/49 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
2/33 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
COVID-19
|
17.4%
8/46 • Number of events 8 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
14.3%
7/49 • Number of events 7 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
19.1%
9/47 • Number of events 9 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
20.9%
9/43 • Number of events 9 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.8%
1/21 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
22.7%
5/22 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
15.6%
7/45 • Number of events 7 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
26.7%
12/45 • Number of events 12 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
15.2%
5/33 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
GASTROENTERITIS
|
6.5%
3/46 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.1%
1/47 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.3%
1/43 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
3.0%
1/33 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.5%
3/46 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
8.2%
4/49 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.3%
2/47 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.3%
4/43 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
14.3%
3/21 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
13.6%
3/22 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.4%
2/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
2/33 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
3/49 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.3%
2/47 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
14.3%
3/21 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
8.9%
4/45 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.1%
3/33 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.5%
3/46 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.0%
1/49 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
8.5%
4/47 • Number of events 7 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.7%
2/43 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
13.6%
3/22 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.4%
2/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.5%
2/21 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/47 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.7%
3/45 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Investigations
WEIGHT INCREASED
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.1%
1/47 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
7.0%
3/43 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
2/33 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Nervous system disorders
HEADACHE
|
8.7%
4/46 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
19.1%
9/47 • Number of events 11 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.7%
2/43 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.5%
2/21 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.5%
1/22 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.4%
2/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
11.1%
5/45 • Number of events 5 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
2/33 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Psychiatric disorders
ANXIETY
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.0%
1/49 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.4%
3/47 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/46 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/49 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.4%
3/47 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/43 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/22 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/33 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.2%
1/46 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.1%
2/49 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
8.5%
4/47 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.7%
2/43 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/21 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.5%
1/22 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
0.00%
0/45 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
3.0%
1/33 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.2%
1/46 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
6.1%
3/49 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
8.5%
4/47 • Number of events 4 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
14.0%
6/43 • Number of events 7 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.8%
1/21 • Number of events 1 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.1%
2/22 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
2.2%
1/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
4.4%
2/45 • Number of events 2 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
9.1%
3/33 • Number of events 3 • All-cause mortality/adverse events were collected from informed consent through the end of the study. Median time on follow-up was 168 days for all groups in Period 1. Median time on follow-up for Period 2 was as follows: Placebo Period 1, Then Upa 11 mg Period 2 (198 days); Placebo Period 1, Then Upa 22 mg Period 2 and Upa 22 mg Period 1, Then Upa 22 mg Period 2 (212 days); Upa 6 mg Period 1, Then Upa 6 mg Period 2 (204 days); and Upa 11 mg Period 1, Then Upa 11 mg Period 2 (207 days).
|
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