Trial Outcomes & Findings for A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease (NCT NCT01683409)
NCT ID: NCT01683409
Last Updated: 2019-09-30
Results Overview
UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to \<50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2019-09-30
Participant Flow
The study included a 24-week treatment period and a 4- to 8-week washout period where study drug was discontinued. Time to loss-of-treatment benefit (defined as a failure to maintain a 30% decrease in UACR from baseline) was evaluated at Week 28. Participants who maintained treatment benefit were followed for an additional 4 weeks.
Participants in each baricitinib dose group were classified by their baseline estimated glomerular filtration rate (eGFR) into higher (50 to 70 milliliter \[mL\]/minute \[min\]/1.73 meters squared \[m²\]) and lower (25 to \<50 mL/min/1.73 m²) eGFR strata. Participants in the lower strata had their dose adjusted to a lower dose.
Participant milestones
| Measure |
Placebo
Placebo administered orally (PO) once a day (QD).
|
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
|
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Treatment Period (Weeks 1-24)
STARTED
|
27
|
25
|
27
|
26
|
25
|
|
Treatment Period (Weeks 1-24)
Received at Least One Dose of Study Drug
|
27
|
25
|
26
|
26
|
25
|
|
Treatment Period (Weeks 1-24)
COMPLETED
|
27
|
21
|
26
|
24
|
23
|
|
Treatment Period (Weeks 1-24)
NOT COMPLETED
|
0
|
4
|
1
|
2
|
2
|
|
Washout Period 1 (Weeks 25-28)
STARTED
|
27
|
21
|
26
|
24
|
23
|
|
Washout Period 1 (Weeks 25-28)
COMPLETED
|
24
|
17
|
25
|
22
|
20
|
|
Washout Period 1 (Weeks 25-28)
NOT COMPLETED
|
3
|
4
|
1
|
2
|
3
|
|
Washout Period 2 (Weeks 29-32)
STARTED
|
6
|
6
|
8
|
6
|
12
|
|
Washout Period 2 (Weeks 29-32)
COMPLETED
|
6
|
6
|
7
|
6
|
9
|
|
Washout Period 2 (Weeks 29-32)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered orally (PO) once a day (QD).
|
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
|
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Treatment Period (Weeks 1-24)
Inappropriately Enrolled
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period (Weeks 1-24)
Adverse Event
|
0
|
3
|
0
|
1
|
1
|
|
Treatment Period (Weeks 1-24)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period (Weeks 1-24)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
|
Washout Period 1 (Weeks 25-28)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period 1 (Weeks 25-28)
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
|
Washout Period 1 (Weeks 25-28)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
|
Washout Period 1 (Weeks 25-28)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (Weeks 25-28)
Adverse Event
|
0
|
4
|
0
|
1
|
2
|
|
Washout Period 2 (Weeks 29-32)
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Washout Period 2 (Weeks 29-32)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Placebo administered PO QD.
|
Baricitinib 0.75/0.5 mg QD
n=25 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg QD
n=26 Participants
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 Participants
Baricitinib 4 mg or 2.75 administered PO QD.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
61 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
64 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
61 Years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
63 Years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
63 Years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
94 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
104 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
60 Participants
n=8 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
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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=8 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who received at least one dose of study drug.
UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to \<50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=25 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=26 Participants
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 Participants
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
|
1.12 milligram/gram (mg/g)
Standard Error 0.172
|
0.87 milligram/gram (mg/g)
Standard Error 0.155
|
0.85 milligram/gram (mg/g)
Standard Error 0.131
|
0.91 milligram/gram (mg/g)
Standard Error 0.143
|
0.66 milligram/gram (mg/g)
Standard Error 0.111
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who received at least one dose of study drug.
Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=25 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=26 Participants
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 Participants
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatinine Clearance at Week 24
|
0.93 milliliter/minute (mL/min)
Standard Error 0.070
|
1.09 milliliter/minute (mL/min)
Standard Error 0.104
|
0.86 milliliter/minute (mL/min)
Standard Error 0.069
|
0.86 milliliter/minute (mL/min)
Standard Error 0.069
|
0.080 milliliter/minute (mL/min)
Standard Error 0.066
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=25 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=26 Participants
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 Participants
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
Index Score (UK Algorithm) Week 24
|
0.00 Units on a Scale
Standard Error 0.03
|
-0.03 Units on a Scale
Standard Error 0.03
|
-0.01 Units on a Scale
Standard Error 0.03
|
-0.04 Units on a Scale
Standard Error 0.03
|
0.00 Units on a Scale
Standard Error 0.03
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
Index Score (US Algorithm) Week 24
|
0.00 Units on a Scale
Standard Error 0.02
|
-0.03 Units on a Scale
Standard Error 0.02
|
0.00 Units on a Scale
Standard Error 0.02
|
-0.03 Units on a Scale
Standard Error 0.02
|
0.00 Units on a Scale
Standard Error 0.02
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
Self-Perceived Health Score
|
2.62 Units on a Scale
Standard Error 2.94
|
-1.97 Units on a Scale
Standard Error 3.02
|
0.28 Units on a Scale
Standard Error 2.95
|
-5.66 Units on a Scale
Standard Error 2.96
|
0.37 Units on a Scale
Standard Error 3.02
|
SECONDARY outcome
Timeframe: Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 Participants
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=25 Participants
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)
|
198 nanomole*hour (nM*hr)
Standard Deviation 89.9
|
286 nanomole*hour (nM*hr)
Standard Deviation 92.4
|
388 nanomole*hour (nM*hr)
Standard Deviation 151
|
1250 nanomole*hour (nM*hr)
Standard Deviation 577
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg QD
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg BID
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Baricitinib 1.5 mg/1 mg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Baricitinib 4 mg/2.75 mg
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo - Washout 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg QD - Washout 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg BID - Washout 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Baricitinib 1.5 mg/1 mg - Washout 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Baricitinib 4 mg/2.75 mg - Washout 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Washout 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg QD - Washout 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Baricitinib 0.75 mg/0.5 mg BID - Washout 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Baricitinib 1.5 mg/1 mg - Washout 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib 4 mg/2.75 mg - Washout 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=25 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=26 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
Placebo - Washout 1
n=27 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD - Washout 1
n=21 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID - Washout 1
n=26 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg - Washout 1
n=24 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg - Washout 1
n=23 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
Placebo Washout 2
n=6 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD - Washout 2
n=6 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID - Washout 2
n=8 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg - Washout 2
n=6 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg - Washout 2
n=12 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Pericardial effusion
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Pancreatitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD
n=25 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID
n=26 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg
n=26 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg
n=25 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
Placebo - Washout 1
n=27 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD - Washout 1
n=21 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID - Washout 1
n=26 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg - Washout 1
n=24 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg - Washout 1
n=23 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
Placebo Washout 2
n=6 participants at risk
Placebo administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg QD - Washout 2
n=6 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
|
Baricitinib 0.75 mg/0.5 mg BID - Washout 2
n=8 participants at risk
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
|
Baricitinib 1.5 mg/1 mg - Washout 2
n=6 participants at risk
Baricitinib 1.5 mg or 1 mg administered PO QD.
|
Baricitinib 4 mg/2.75 mg - Washout 2
n=12 participants at risk
Baricitinib 4 mg or 2.75 mg administered PO QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal impairment
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27
|
4.0%
1/25 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • Number of events 2
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Hot flush
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Microscopic polyangiitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
1/27 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
28.0%
7/25 • Number of events 7
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Angina unstable
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Dry eye
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Eye pruritus
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27
|
8.0%
2/25 • Number of events 2
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
12.0%
3/25 • Number of events 4
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Reflux gastritis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Chest pain
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Chills
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Fatigue
|
0.00%
0/27
|
0.00%
0/25
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Injection site nodule
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Malaise
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Oedema peripheral
|
7.4%
2/27 • Number of events 3
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Thirst
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Hepatobiliary disorders
Hepatic steatosis
|
3.7%
1/27 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Immune system disorders
Food allergy
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Bronchitis
|
3.7%
1/27 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Cystitis
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Folliculitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Gastroenteritis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Helicobacter infection
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Influenza
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Localised infection
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27 • Number of events 1
|
16.0%
4/25 • Number of events 6
|
15.4%
4/26 • Number of events 4
|
15.4%
4/26 • Number of events 4
|
12.0%
3/25 • Number of events 4
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Otitis externa
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Otitis media
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 2
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Tinea pedis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Urethritis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.4%
2/27 • Number of events 2
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 2
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/21
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
7.4%
2/27 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27
|
8.0%
2/25 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
12.0%
3/25 • Number of events 4
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Haematocrit decreased
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Heart rate decreased
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Lipase increased
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Occult blood
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Occult blood positive
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Vitamin D decreased
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
4.8%
1/21 • Number of events 1
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
White blood cells urine positive
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/27
|
12.0%
3/25 • Number of events 3
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.8%
4/27 • Number of events 5
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Number of events 2
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
1/27 • Number of events 1
|
0.00%
0/25
|
11.5%
3/26 • Number of events 3
|
3.8%
1/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
3.7%
1/27 • Number of events 1
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
8.0%
2/25 • Number of events 3
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27
|
4.0%
1/25 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27
|
4.0%
1/25 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
|
Psychiatric disorders
Head banging
|
0.00%
0/27
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27
|
0.00%
0/25
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/27
|
0.00%
0/21
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/23
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/12
|
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