Trial Outcomes & Findings for Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy (NCT NCT01469013)
NCT ID: NCT01469013
Last Updated: 2019-09-20
Results Overview
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) \* 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-09-20
Participant Flow
Participants on background methotrexate therapy were assigned to a dose of 1, 2, 4, 8 mg baricitinib (LY3009104) or placebo capsule once daily in a double blind manner for 12 weeks followed by single blind treatment of 4 mg or 8 mg baricitinib (LY3009104) tablet once daily for 52 weeks extension period.
Participant milestones
| Measure |
Part A: 1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
|
Part A: 2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Part A: 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
Part A: 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Part A: Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
Part:1 mg Baricitinib(LY3009104) / 4 mg Baricitinib(LY3009104)
Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: Placebo /4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY300
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: Placebo / 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (Treatment Period)
STARTED
|
24
|
24
|
24
|
24
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Treatment Period)
Received at Least 1 Dose of Study Drug
|
24
|
24
|
24
|
24
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Treatment Period)
COMPLETED
|
23
|
24
|
23
|
24
|
48
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Treatment Period)
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Extension Period)
STARTED
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
23
|
24
|
11
|
12
|
24
|
24
|
|
Part B (Extension Period)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
23
|
24
|
11
|
12
|
24
|
23
|
|
Part B (Extension Period)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
10
|
7
|
18
|
20
|
8
|
10
|
18
|
18
|
|
Part B (Extension Period)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
5
|
4
|
3
|
2
|
6
|
6
|
Reasons for withdrawal
| Measure |
Part A: 1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
|
Part A: 2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Part A: 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
Part A: 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Part A: Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
Part:1 mg Baricitinib(LY3009104) / 4 mg Baricitinib(LY3009104)
Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: Placebo /4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Part B: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY300
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part B: Placebo / 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (Treatment Period)
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (Treatment Period)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Extension Period)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
5
|
3
|
3
|
1
|
6
|
3
|
|
Part B (Extension Period)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
3
|
Baseline Characteristics
Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Part A: 1 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy were administered 1 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part A: 2 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy were administered 2 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part A: 4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy were administered 4 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part A: 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy were administered 8 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Part A: Placebo
n=49 Participants
Participants on background methotrexate therapy were administered placebo orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Region of Enrollment
Japan
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
145 Participants
n=10 Participants
|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
51.1 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
53.6 years
STANDARD_DEVIATION 11.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
118 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
145 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
145 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All participants who received at least 1 dose of 4 mg, 8 mg baricitinib (LY3009104) or placebo in Part A as per protocol for combined analysis .
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=48 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12 .
|
77 percentage of participants
|
31 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any amount of study drug in Part B.
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI which measured participants perceived degree of difficulty performing daily activities, CRP and ESR, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an ACR20 Response at 64 Weeks
|
66 percentage of participants
|
73 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any study drug in Part A.
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 responders / number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an ACR70 Response at 12 Weeks (Part A)
|
13 percentage of participants
|
29 percentage of participants
|
29 percentage of participants
|
21 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any study drug in Part B.
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR70 response=(number of ACR70 responders) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an ACR70 Response at 64 Weeks (Part B)
|
37 percentage of participants
|
34 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received any study drug in Part A and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP \[milligrams per liter (mg/L)\], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
|
-1.52 units on a scale
Standard Deviation 0.970
|
-2.02 units on a scale
Standard Deviation 1.072
|
-2.09 units on a scale
Standard Deviation 1.105
|
-1.96 units on a scale
Standard Deviation 0.947
|
-0.60 units on a scale
Standard Deviation 1.204
|
SECONDARY outcome
Timeframe: Baseline, 64 weeksPopulation: All randomized participants who received any study drug in Part B and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 64 in DAS Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
|
-2.44 units on a scale
Standard Deviation 1.152
|
-2.48 units on a scale
Standard Deviation 1.109
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any amount of study drug in Part A.
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \>5.1, low disease activity: DAS28-CRP ≤3.2, and remission: DAS28-CRP \<2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: ≤3.2 and \>1.2 improvement from baseline), moderate (absolute: \>3.2 and ≤5.1 and \>0.6 and ≤1.2 improvement from baseline), or no response (absolute: \>5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)
|
83 percentage of participants
|
88 percentage of participants
|
92 percentage of participants
|
92 percentage of participants
|
47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any amount of study drug in Part B.
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \>5.1, low disease activity: DAS28-CRP \<3.2, and remission: DAS28-CRP \<2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and \>1.2 improvement from baseline), moderate (absolute: \>3.2 and ≤5.1 and \>0.6 and ≤1.2 improvement from baseline), or no response (absolute: \>5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)
|
94 percentage of participants
|
94 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any amount of study drug in Part A and had SDAI data at analysis time points. The last non-missing post-baseline value in Part A was used.
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)
|
-13.11 units on a scale
Standard Deviation 8.918
|
-16.85 units on a scale
Standard Deviation 9.517
|
-18.17 units on a scale
Standard Deviation 9.202
|
-18.02 units on a scale
Standard Deviation 8.293
|
-4.54 units on a scale
Standard Deviation 13.113
|
SECONDARY outcome
Timeframe: Baseline, 64 weeksPopulation: All participants who received any amount of study drug in Part B and had data for SDAI at analysis time points. The last non-missing post-baseline value in Part B was used.
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI: SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS/ 10, with lower values indicating fewer symptoms.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change in SDAI Responses up to 64 Weeks (Part B)
|
-20.42 units on a scale
Standard Deviation 9.671
|
-21.33 units on a scale
Standard Deviation 10.318
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants who received any amount of study drug in Part A and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)
|
-0.302 units on a scale
Standard Deviation 0.3336
|
-0.396 units on a scale
Standard Deviation 0.4759
|
-0.469 units on a scale
Standard Deviation 0.3463
|
-0.422 units on a scale
Standard Deviation 0.3646
|
-0.077 units on a scale
Standard Deviation 0.3552
|
SECONDARY outcome
Timeframe: Baseline, 64 weeksPopulation: All participants who received any amount of study drug in Part B and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Change in HAQ-DI Responses up to 64 Weeks (Part B)
|
-0.498 units on a scale
Standard Deviation 0.4779
|
-0.568 units on a scale
Standard Deviation 0.6203
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any study drug in Part A and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=23 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=23 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=48 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Value of ACR-N Response (Part A)
|
28.76 percentage of responders
Standard Deviation 38.65
|
42.48 percentage of responders
Standard Deviation 39.52
|
45.17 percentage of responders
Standard Deviation 33.75
|
25.58 percentage of responders
Standard Deviation 130.02
|
-9.98 percentage of responders
Standard Deviation 58.10
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any study drug in Part B and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=55 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=54 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Mean Value of ACR-N Response (Part B)
|
61.14 percentage of responders
Standard Deviation 30.70
|
61.07 percentage of responders
Standard Deviation 33.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any amount of study treatment in Part A.
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. For remission, DAS28 is \<2.6. Percentage of participants = (number of participants with DAS28 remission) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a DAS28 Remission at 12 Weeks (Part A)
|
33 percentage of participants
|
33 percentage of participants
|
42 percentage of participants
|
50 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any amount of study drug in Part B.
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. For remission, DAS28 is \<2.6. Percentage of participants = (number of participants with DAS 28 remission) / (number of participants treated) \* 100.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a DAS28 Remission at 64 Weeks (Part B)
|
66 percentage of participants
|
66 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: All participants who received any amount of study drug in Part A.
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA and CRP. The equation used to calculate the SDAI: SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) \* 100
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
n=49 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an SDAI Remission at 12 Weeks (Part A)
|
4 percentage of participants
|
29 percentage of participants
|
17 percentage of participants
|
17 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 64 weeksPopulation: All participants who received any amount of study drug in Part B.
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI: SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) \* 100
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=71 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=70 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an SDAI Remission at 64 Weeks (Part B)
|
39 percentage of participants
|
39 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.Population: All participants who received any study drug and had evaluable data for AUC(tau,ss).
Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=48 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=47 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
|
237 nanomoles*hour (nM*h)
Geometric Coefficient of Variation 28.8
|
525 nanomoles*hour (nM*h)
Geometric Coefficient of Variation 21
|
1020 nanomoles*hour (nM*h)
Geometric Coefficient of Variation 32.5
|
1900 nanomoles*hour (nM*h)
Geometric Coefficient of Variation 24.1
|
—
|
SECONDARY outcome
Timeframe: Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.Population: All participants who received any study drug and had evaluable Cmax data.
Outcome measures
| Measure |
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
n=24 Participants
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
|
Part A: Placebo
n=24 Participants
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=48 Participants
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=47 Participants
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
|
35.7 nM
Geometric Coefficient of Variation 20.9
|
73.5 nM
Geometric Coefficient of Variation 22.5
|
147 nM
Geometric Coefficient of Variation 20.6
|
278 nM
Geometric Coefficient of Variation 21.7
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
1 mg Baricitinib (LY3009104)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
2 mg Baricitinib (LY3009104)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
4 mg Baricitinib (LY3009104)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
8 mg Baricitinib (LY3009104)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo / 4 mg Baricitinib (LY3009104)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo /8 mg Baricitinib (LY3009104)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
1 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
|
2 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo / 4 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
n=23 participants at risk
Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Placebo /8 mg Baricitinib (LY3009104)
n=23 participants at risk
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=11 participants at risk
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy who were administered 8 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Eye disorders
Cataract
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
|
1 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
|
2 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
4 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
|
8 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
|
Placebo / 4 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
1 mg Baricitinib (LY3009104) / 4mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY3009104)
n=23 participants at risk
Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
|
Placebo /8 mg Baricitinib (LY3009104)
n=23 participants at risk
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=11 participants at risk
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=12 participants at risk
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY3009104)
n=24 participants at risk
Participants on background methotrexate therapy who were administered 8 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.3%
1/23 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
13.0%
3/23 • Number of events 4
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
13.0%
3/23 • Number of events 4
|
13.0%
3/23 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Endocrine disorders
Thyroiditis chronic
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Eye disorders
Cataract
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Eye disorders
Dry eye
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
8.7%
2/23 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
13.0%
3/23 • Number of events 3
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/24
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
8.3%
2/24 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Chest discomfort
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Chest pain
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Malaise
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Mass
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Oedema
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Oedema peripheral
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
General disorders
Pyrexia
|
4.1%
2/49 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/49
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
13.0%
3/23 • Number of events 4
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Immune system disorders
Seasonal allergy
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
8.7%
2/23 • Number of events 2
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Bronchitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 2
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Cystitis
|
4.1%
2/49 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Eczema impetiginous
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Empyema
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Folliculitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Fungal paronychia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Furuncle
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 2
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Genital herpes
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Gingivitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Influenza
|
2.0%
1/49 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
6/49 • Number of events 7
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
41.7%
5/12 • Number of events 6
|
50.0%
6/12 • Number of events 6
|
30.4%
7/23 • Number of events 8
|
39.1%
9/23 • Number of events 15
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
20.8%
5/24 • Number of events 9
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Oral herpes
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Paronychia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Periodontitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Pertussis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/49 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 6
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Skin candida
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Skin infection
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • Number of events 1
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
8.7%
2/23 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Viral infection
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Infections and infestations
Viral rash
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
4.1%
2/49 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
16.7%
4/24 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
13.0%
3/23 • Number of events 3
|
17.4%
4/23 • Number of events 5
|
18.2%
2/11 • Number of events 2
|
16.7%
2/12 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 2
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Cell marker increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Colonoscopy
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Electrocardiogram st-t segment abnormal
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Endoscopy
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Eosinophil count increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Lipids abnormal
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Liver function test abnormal
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Oesophagogastroduodenoscopy
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Transaminases increased
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Weight decreased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Investigations
Weight increased
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 2
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
8.7%
2/23 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
1/49 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
18.2%
2/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Sciatica
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Psychiatric disorders
Head banging
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Renal and urinary disorders
Hypertonic bladder
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/39
|
0.00%
0/22
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/17
|
0.00%
0/21
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/18
|
0.00%
0/17
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Menstrual disorder
|
2.6%
1/39 • Number of events 1
|
0.00%
0/22
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/17
|
0.00%
0/21
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/18
|
0.00%
0/17
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/39
|
0.00%
0/22
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/17
|
0.00%
0/21
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/18
|
5.9%
1/17 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
18.2%
2/11 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/49 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
4.3%
1/23 • Number of events 3
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
|
Surgical and medical procedures
Cholecystectomy
|
2.0%
1/49 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Surgical and medical procedures
Drug delivery device implantation
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Surgical and medical procedures
External fixation of fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Gastrointestinal endoscopic therapy
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 2
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Removal of foreign body
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
8.7%
2/23 • Number of events 2
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
4.3%
1/23 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Vascular disorders
Hypertension
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/49
|
0.00%
0/24
|
4.2%
1/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
|
Vascular disorders
Varicose vein
|
0.00%
0/49
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/24
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60