Trial Outcomes & Findings for A Phase 2b Diabetic Kidney Disease Study (NCT NCT04170543)
NCT ID: NCT04170543
Last Updated: 2024-07-10
Results Overview
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
609 participants
Primary outcome timeframe
From baseline to Day 169
Results posted on
2024-07-10
Participant Flow
The following data were excluded from this analysis: * Data from patients enrolled in Phase 2a of the study: This phase was discontinued due to the COVID-19 pandemic. * Data from patients enrolled at a site that was discovered to not follow Good Clinical Practice (GCP) guidelines. * Data from patients not treated.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive Placebo
|
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
|
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
|
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
|
MEDI3506 300 mg
Participants were randomized to receive tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
96
|
101
|
95
|
160
|
|
Overall Study
COMPLETED
|
99
|
70
|
70
|
68
|
120
|
|
Overall Study
NOT COMPLETED
|
48
|
26
|
31
|
27
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive Placebo
|
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
|
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
|
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
|
MEDI3506 300 mg
Participants were randomized to receive tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
6
|
5
|
4
|
9
|
|
Overall Study
Not able to transition to phase 2b
|
8
|
0
|
10
|
0
|
6
|
|
Overall Study
Enrolled in Site with GCP Breach
|
6
|
1
|
2
|
2
|
4
|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
(CRF)
|
16
|
15
|
12
|
17
|
17
|
|
Overall Study
Due to COVID-19 Pandemic
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 2b Diabetic Kidney Disease Study
Baseline characteristics by cohort
| Measure |
Placebo
n=133 Participants
Participants were randomized to receive Placebo
|
MEDI3506 30 mg
n=95 Participants
Participants were randomized to receive tozorakimab 30 mg
|
MEDI3506 60 mg
n=89 Participants
Participants were randomized to receive tozorakimab 60 mg
|
MEDI3506 120 mg
n=93 Participants
Participants were randomized to receive tozorakimab 120 mg
|
MEDI3506 300 mg
n=148 Participants
Participants were randomized to receive tozorakimab 300 mg
|
Total
n=558 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
65.9 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
66.6 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Sex · Female
|
46 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
169 Participants
n=8 Participants
|
|
Sex: Female, Male
Sex · Male
|
87 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
389 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
288 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
270 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · 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)
Race · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Race · White
|
81 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
364 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Race · 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)
Race · Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Region of Enrollment
Argentina
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
113 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Region of Enrollment
Chile
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Region of Enrollment
Korea, Republic of; South Korea
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Peru
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
274 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 169Population: Per Protocol Population: All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Outcome measures
| Measure |
Placebo
n=103 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=81 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=78 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=72 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=131 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
|
-14.82 Percentage change from baseline
Interval -27.05 to -0.53
|
-17.25 Percentage change from baseline
Interval -30.69 to -1.19
|
-31.45 Percentage change from baseline
Interval -42.54 to -18.21
|
-29.70 Percentage change from baseline
Interval -41.61 to -15.37
|
-20.96 Percentage change from baseline
Interval -31.32 to -9.04
|
SECONDARY outcome
Timeframe: From baseline to Day 85Population: Per Protocol Population: All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Outcome measures
| Measure |
Placebo
n=103 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=81 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=78 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=72 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=131 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
|
21.60 Percentage change from baseline
Interval 7.39 to 37.7
|
5.77 Percentage change from baseline
Interval -8.0 to 21.6
|
-9.66 Percentage change from baseline
Interval -21.46 to 3.91
|
-0.53 Percentage change from baseline
Interval -14.1 to 15.18
|
2.69 Percentage change from baseline
Interval -8.32 to 15.01
|
SECONDARY outcome
Timeframe: From Day 85 to Day 169Population: Per Protocol Population: All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from Day 85 up to Day 169.
Outcome measures
| Measure |
Placebo
n=103 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=81 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=78 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=72 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=131 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
|
-23.26 Percentage change from baseline
Interval -32.77 to -12.39
|
-17.69 Percentage change from baseline
Interval -29.17 to -4.36
|
-20.87 Percentage change from baseline
Interval -31.7 to -8.32
|
-25.87 Percentage change from baseline
Interval -36.49 to -13.47
|
-19.21 Percentage change from baseline
Interval -28.28 to -9.0
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: Per Protocol Population: All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. Only participants with values at Baseline and Day 169 are included.
Outcome measures
| Measure |
Placebo
n=97 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=73 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=74 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=67 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=123 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR reduction > 30%
|
43 Participants
|
34 Participants
|
28 Participants
|
38 Participants
|
59 Participants
|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR reduction > 40%
|
33 Participants
|
23 Participants
|
23 Participants
|
29 Participants
|
45 Participants
|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR reduction > 50%
|
22 Participants
|
17 Participants
|
19 Participants
|
23 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: From baseline to Day 169Population: Full Analysis Population: All randomized participants who received any study drug.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Outcome measures
| Measure |
Placebo
n=133 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=95 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=89 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=93 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=148 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
|
-15.82 Percentage change from baseline
Interval -27.33 to -2.49
|
-13.77 Percentage change from baseline
Interval -27.25 to 2.2
|
-28.98 Percentage change from baseline
Interval -40.2 to -15.64
|
-30.94 Percentage change from baseline
Interval -41.93 to -17.86
|
-21.19 Percentage change from baseline
Interval -31.29 to -9.59
|
SECONDARY outcome
Timeframe: From baseline to Day 85Population: Full Analysis Population: All randomized participants who received any study drug.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Outcome measures
| Measure |
Placebo
n=133 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=95 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=89 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=93 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=148 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
|
16.86 Percentage change from baseline
Interval 3.59 to 31.83
|
7.59 Percentage change from baseline
Interval -6.16 to 23.35
|
-7.23 Percentage change from baseline
Interval -19.29 to 6.63
|
-5.03 Percentage change from baseline
Interval -17.55 to 9.39
|
1.35 Percentage change from baseline
Interval -9.52 to 13.53
|
SECONDARY outcome
Timeframe: Baseline and Day 169Population: Full Analysis Population: All randomized participants who received any study drug.
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. Only participants with values at Baseline and Day 169 are included.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=80 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=78 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=77 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=130 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR reduction > 40%
|
37 Participants
|
25 Participants
|
23 Participants
|
32 Participants
|
48 Participants
|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR reduction > 50%
|
26 Participants
|
18 Participants
|
19 Participants
|
26 Participants
|
38 Participants
|
|
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR reduction > 30%
|
49 Participants
|
36 Participants
|
28 Participants
|
41 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 230Population: PK Analysis Population: All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment.
ADA prevalence: number of participants ADA positive (ADA+) at baseline and/or post-baseline. Treatment-induced ADA+: ADA not detected or missing at baseline and at least one post-baseline ADA+. Treatment-boosted ADA+: ADA+ at baseline and baseline titre is boosted by ≥ 4-fold increase at ≥ 1 post-baseline time point. Treatment-emergent ADA+ (TE-ADA + or ADA incidence): Treatment-induced ADA+ OR and Treatment-boosted ADA+.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=92 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=86 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=90 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=146 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Immunogenicity of MEDI3506 - PK Analysis Population
Treatment-emergent ADA+ (Treatment-induced ADA+ or Treatment-boosted ADA+)
|
1 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
14 Participants
|
|
Immunogenicity of MEDI3506 - PK Analysis Population
Treatment-induced ADA+
|
1 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
|
Immunogenicity of MEDI3506 - PK Analysis Population
Treatment-boosted ADA+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 230Population: Safety Analysis Population: All randomized participants who received any study drug. Subset of participants tested positive for COVID-19 during the study.
Participants were tested for COVID-19 during the course of the study. Descriptive analysis of asymptomatic participants tested positive for COVID-19 during the study.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=58 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=53 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=56 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=73 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
|
79 Participants
|
54 Participants
|
50 Participants
|
53 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 230For participants tested positive for COVID-19 during the intervention and follow-up periods, this analysis provides: * the number and proportion of subjects with any treatment-emergent adverse event * the number and proportion of subjects with any treatment-emergent serious adverse event
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=58 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=53 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=56 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=73 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
Any adverse event
|
47 Participants
|
35 Participants
|
23 Participants
|
30 Participants
|
40 Participants
|
|
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
Any serious adverse event
|
11 Participants
|
9 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 29, Day 85 and Day 169Population: PK Analysis Population: All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment.
MEDI3506/Tozorakimab serum concentrations were measured using a validated assay method.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received Placebo
|
MEDI3506 30 mg
n=94 Participants
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=88 Participants
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=92 Participants
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=147 Participants
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Plasma Concentration of MEDI3506 - PK Analysis Population
Day 1
|
0.01063 ng/mL
Geometric Coefficient of Variation 418.9
|
0.005232 ng/mL
Geometric Coefficient of Variation 38.16
|
0.005261 ng/mL
Geometric Coefficient of Variation 33.33
|
0.005111 ng/mL
Geometric Coefficient of Variation 12.30
|
0.005443 ng/mL
Geometric Coefficient of Variation 79.38
|
|
Plasma Concentration of MEDI3506 - PK Analysis Population
Day 29
|
0.01983 ng/mL
Geometric Coefficient of Variation 533.3
|
0.2185 ng/mL
Geometric Coefficient of Variation 110.3
|
0.4454 ng/mL
Geometric Coefficient of Variation 144.4
|
0.7036 ng/mL
Geometric Coefficient of Variation 119.7
|
1.884 ng/mL
Geometric Coefficient of Variation 64.34
|
|
Plasma Concentration of MEDI3506 - PK Analysis Population
Day 85
|
0.02898 ng/mL
Geometric Coefficient of Variation 711.3
|
0.2754 ng/mL
Geometric Coefficient of Variation 155.6
|
0.4701 ng/mL
Geometric Coefficient of Variation 140.1
|
0.9547 ng/mL
Geometric Coefficient of Variation 103.2
|
2.326 ng/mL
Geometric Coefficient of Variation 80.10
|
|
Plasma Concentration of MEDI3506 - PK Analysis Population
Day 169
|
0.02435 ng/mL
Geometric Coefficient of Variation 919.4
|
0.2495 ng/mL
Geometric Coefficient of Variation 132.2
|
0.4231 ng/mL
Geometric Coefficient of Variation 188.4
|
0.7027 ng/mL
Geometric Coefficient of Variation 200.1
|
2.402 ng/mL
Geometric Coefficient of Variation 91.04
|
Adverse Events
Placebo
Serious events: 15 serious events
Other events: 62 other events
Deaths: 1 deaths
MEDI3506 30 mg
Serious events: 14 serious events
Other events: 55 other events
Deaths: 1 deaths
MEDI3506 60 mg
Serious events: 5 serious events
Other events: 39 other events
Deaths: 1 deaths
MEDI3506 120 mg
Serious events: 12 serious events
Other events: 48 other events
Deaths: 1 deaths
MEDI3506 300 mg
Serious events: 11 serious events
Other events: 74 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=133 participants at risk
Participants received Placebo
|
MEDI3506 30 mg
n=95 participants at risk
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=89 participants at risk
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=93 participants at risk
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=148 participants at risk
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Covid-19
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Gangrene
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Influenza
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Osteomyelitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Pneumonia aspiration
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Septic shock
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardiac arrest
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Urosepsis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardiac failure
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Hypertension
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Hypotension
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Shock
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Ear and labyrinth disorders
Vertigo
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Retinal detachment
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Appendicitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
Other adverse events
| Measure |
Placebo
n=133 participants at risk
Participants received Placebo
|
MEDI3506 30 mg
n=95 participants at risk
Participants received tozorakimab 30 mg
|
MEDI3506 60 mg
n=89 participants at risk
Participants received tozorakimab 60 mg
|
MEDI3506 120 mg
n=93 participants at risk
Participants received tozorakimab 120 mg
|
MEDI3506 300 mg
n=148 participants at risk
Participants received tozorakimab 300 mg
|
|---|---|---|---|---|---|
|
Investigations
Blood pressure decreased
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Blood pressure increased
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Brain natriuretic peptide increased
|
2.3%
3/133 • Number of events 3 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
C-reactive protein increased
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Lipase increased
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Occult blood positive
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Covid-19
|
4.5%
6/133 • Number of events 6 • Day 1 to Day 230
|
3.2%
3/95 • Number of events 3 • Day 1 to Day 230
|
3.4%
3/89 • Number of events 3 • Day 1 to Day 230
|
4.3%
4/93 • Number of events 4 • Day 1 to Day 230
|
3.4%
5/148 • Number of events 5 • Day 1 to Day 230
|
|
Infections and infestations
Candida infection
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Cellulitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Ear infection
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Folliculitis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Gangrene
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Infections and infestations
Genital infection fungal
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Influenza
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
4/133 • Number of events 4 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 2 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Oesophageal candidiasis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Otitis externa
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Otitis media
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Pneumonia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Respiratory tract infection
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Sinusitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Tooth infection
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
3.2%
3/93 • Number of events 4 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Urinary tract infection
|
3.8%
5/133 • Number of events 5 • Day 1 to Day 230
|
3.2%
3/95 • Number of events 4 • Day 1 to Day 230
|
4.5%
4/89 • Number of events 4 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
2.0%
3/148 • Number of events 3 • Day 1 to Day 230
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 3 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 2 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Blood creatinine increased
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 3 • Day 1 to Day 230
|
|
Investigations
Blood glucose increased
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Platelet count increased
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Pulse absent
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Investigations
Troponin increased
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Venous pressure jugular increased
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Investigations
Weight increased
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Gout
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.8%
5/133 • Number of events 5 • Day 1 to Day 230
|
4.2%
4/95 • Number of events 7 • Day 1 to Day 230
|
5.6%
5/89 • Number of events 5 • Day 1 to Day 230
|
3.2%
3/93 • Number of events 3 • Day 1 to Day 230
|
6.1%
9/148 • Number of events 10 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/133 • Day 1 to Day 230
|
8.4%
8/95 • Number of events 12 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 2 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
4.2%
4/95 • Number of events 5 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
2.7%
4/148 • Number of events 4 • Day 1 to Day 230
|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
4/133 • Number of events 4 • Day 1 to Day 230
|
5.3%
5/95 • Number of events 5 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 2 • Day 1 to Day 230
|
3.2%
3/93 • Number of events 3 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.75%
1/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 3 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
2/133 • Number of events 3 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
3/133 • Number of events 4 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.75%
1/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Diabetic neuropathy
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Dizziness
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Nervous system disorders
Headache
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Nervous system disorders
Paraesthesia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Sciatica
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Somnolence
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Nervous system disorders
Syncope
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Psychiatric disorders
Delirium
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Palpitations
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Renal and urinary disorders
Azotaemia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Renal and urinary disorders
Haematuria
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Renal and urinary disorders
Hypertonic bladder
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 3 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Renal mass
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Reproductive system and breast disorders
Cystocele
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Reproductive system and breast disorders
Penile size reduced
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
3/133 • Number of events 3 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Diabetic dermopathy
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 3 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Onychogryphosis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 4 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 3 • Day 1 to Day 230
|
|
Skin and subcutaneous tissue disorders
Urticarial vasculitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Flushing
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Haematoma
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Hypertension
|
2.3%
3/133 • Number of events 3 • Day 1 to Day 230
|
6.3%
6/95 • Number of events 6 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
7.5%
7/93 • Number of events 7 • Day 1 to Day 230
|
4.7%
7/148 • Number of events 7 • Day 1 to Day 230
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Vascular disorders
Hypotension
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Ear and labyrinth disorders
Tinnitus
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Ear and labyrinth disorders
Vertigo
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Cataract
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 2 • Day 1 to Day 230
|
|
Eye disorders
Corneal disorder
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Dry eye
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Eye disorders
Glaucoma
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Vision blurred
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Colitis
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Constipation
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
2.2%
2/89 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 2 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
4.5%
4/89 • Number of events 6 • Day 1 to Day 230
|
3.2%
3/93 • Number of events 3 • Day 1 to Day 230
|
2.7%
4/148 • Number of events 4 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Duodenitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Dyspepsia
|
0.75%
1/133 • Number of events 2 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 3 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Nausea
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
2.0%
3/148 • Number of events 3 • Day 1 to Day 230
|
|
General disorders
Asthenia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Chest pain
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Chills
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Fatigue
|
0.00%
0/133 • Day 1 to Day 230
|
2.1%
2/95 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
General disorders
Granuloma
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Hunger
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Angina pectoris
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 3 • Day 1 to Day 230
|
|
General disorders
Hypothermia
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Influenza like illness
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Injection site inflammation
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Injection site pruritus
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 4 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 5 • Day 1 to Day 230
|
|
General disorders
Injection site rash
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Injection site swelling
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Malaise
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Oedema peripheral
|
3.0%
4/133 • Number of events 4 • Day 1 to Day 230
|
4.2%
4/95 • Number of events 4 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
2.2%
2/93 • Number of events 2 • Day 1 to Day 230
|
4.1%
6/148 • Number of events 7 • Day 1 to Day 230
|
|
General disorders
Pain
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Peripheral swelling
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
3.4%
3/89 • Number of events 3 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
General disorders
Pyrexia
|
1.5%
2/133 • Number of events 2 • Day 1 to Day 230
|
4.2%
4/95 • Number of events 4 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
1.4%
2/148 • Number of events 2 • Day 1 to Day 230
|
|
General disorders
Swelling face
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/133 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
1.1%
1/93 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
1.1%
1/89 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/133 • Day 1 to Day 230
|
1.1%
1/95 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.68%
1/148 • Number of events 1 • Day 1 to Day 230
|
|
Infections and infestations
Acute sinusitis
|
0.75%
1/133 • Number of events 1 • Day 1 to Day 230
|
0.00%
0/95 • Day 1 to Day 230
|
0.00%
0/89 • Day 1 to Day 230
|
0.00%
0/93 • Day 1 to Day 230
|
0.00%
0/148 • Day 1 to Day 230
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place