Trial Outcomes & Findings for Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy (NCT NCT04164888)
NCT ID: NCT04164888
Last Updated: 2025-02-13
Results Overview
Percent change from baseline in PCSK9
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Baseline, D29, D57, D85
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo SC injection matching PCSK9 inhibitor given twice
|
Experimental: CIVI 007, Dose A
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
|
Experimental: CIVI 007, Dose B
SC injection of PCSK9 inhibitor- dose titration
|
Experimental: CIVI 007, Dose C
SC injection of PCSK9 inhibitor- high dose given twice
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Baseline characteristics by cohort
| Measure |
CIVI 007, Dose A
n=12 Participants
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose B
n=13 Participants
SC injection of PCSK9 inhibitor- dose titration
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose C
n=12 Participants
SC injection of PCSK9 inhibitor- high dose given twice
CIVI 007: hypercholesterolemia agent
|
Placebo
n=12 Participants
Placebo SC injection matching PCSK9 inhibitor given twice
CIVI 007: hypercholesterolemia agent
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 8.06 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.48 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.93 • n=4 Participants
|
57.6 years
STANDARD_DEVIATION 9.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Childbearing potential, n
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Height
|
171.0 cm
STANDARD_DEVIATION 11.82 • n=5 Participants
|
176.8 cm
STANDARD_DEVIATION 10.58 • n=7 Participants
|
174.9 cm
STANDARD_DEVIATION 9.00 • n=5 Participants
|
170.2 cm
STANDARD_DEVIATION 10.40 • n=4 Participants
|
173.3 cm
STANDARD_DEVIATION 10.54 • n=21 Participants
|
|
Weight
|
89.51 kg
STANDARD_DEVIATION 12.011 • n=5 Participants
|
98.55 kg
STANDARD_DEVIATION 16.473 • n=7 Participants
|
95.30 kg
STANDARD_DEVIATION 18.659 • n=5 Participants
|
82.56 kg
STANDARD_DEVIATION 12.327 • n=4 Participants
|
91.62 kg
STANDARD_DEVIATION 15.924 • n=21 Participants
|
|
Body mass index
|
30.75 kg/m2
STANDARD_DEVIATION 4.432 • n=5 Participants
|
31.50 kg/m2
STANDARD_DEVIATION 4.403 • n=7 Participants
|
31.05 kg/m2
STANDARD_DEVIATION 5.306 • n=5 Participants
|
28.56 kg/m2
STANDARD_DEVIATION 3.893 • n=4 Participants
|
30.48 kg/m2
STANDARD_DEVIATION 4.536 • n=21 Participants
|
|
Body mass index category
less than 30 kg/m2
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Body mass index category
more or equal to 30 kg/m2
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
PCSK9
|
377.13 ug/L
STANDARD_DEVIATION 117.819 • n=5 Participants
|
374.03 ug/L
STANDARD_DEVIATION 106.523 • n=7 Participants
|
467.03 ug/L
STANDARD_DEVIATION 101.657 • n=5 Participants
|
444.43 ug/L
STANDARD_DEVIATION 150.172 • n=4 Participants
|
414.81 ug/L
STANDARD_DEVIATION 123.535 • n=21 Participants
|
|
Fasting LDL-C
|
115.3 mg/dL
STANDARD_DEVIATION 42.49 • n=5 Participants
|
108.2 mg/dL
STANDARD_DEVIATION 27.15 • n=7 Participants
|
102.7 mg/dL
STANDARD_DEVIATION 21.35 • n=5 Participants
|
130.0 mg/dL
STANDARD_DEVIATION 60.39 • n=4 Participants
|
113.9 mg/dL
STANDARD_DEVIATION 40.55 • n=21 Participants
|
|
Taking lower than recommended statin therapy?
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Background statin therapy
High intensity
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Background statin therapy
Moderate intensity
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Background statin therapy
Low intensity
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Background statin therapy
None
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ezetimibe use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, D29, D57, D85Percent change from baseline in PCSK9
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo SC injection matching PCSK9 inhibitor given twice
|
Experimental: CIVI 007, Dose A
n=12 Participants
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
|
Experimental: CIVI 007, Dose B
n=13 Participants
SC injection of PCSK9 inhibitor- dose titration
|
Experimental: CIVI 007, Dose C
n=12 Participants
SC injection of PCSK9 inhibitor- high dose given twice
|
|---|---|---|---|---|
|
Assessment of the Pharmacodynamic Effect of CIVI 007
Day 29
|
-4.54 percentage change from baseline
Interval -15.7 to 63.3
|
-71.38 percentage change from baseline
Interval -89.7 to -63.4
|
-76.01 percentage change from baseline
Interval -92.7 to -18.5
|
-82.27 percentage change from baseline
Interval -93.4 to -48.1
|
|
Assessment of the Pharmacodynamic Effect of CIVI 007
Day 57
|
-7.42 percentage change from baseline
Interval -31.6 to 25.8
|
-81.08 percentage change from baseline
Interval -91.0 to -69.9
|
-85.48 percentage change from baseline
Interval -93.0 to -67.6
|
-83.42 percentage change from baseline
Interval -92.2 to -71.2
|
|
Assessment of the Pharmacodynamic Effect of CIVI 007
Day 85
|
-0.37 percentage change from baseline
Interval -35.5 to 41.2
|
-43.74 percentage change from baseline
Interval -72.9 to -27.0
|
-55.89 percentage change from baseline
Interval -75.1 to -18.7
|
-61.10 percentage change from baseline
Interval -73.6 to -37.8
|
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 57, Day 85Percent change from baseline in LDL-C
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo SC injection matching PCSK9 inhibitor given twice
|
Experimental: CIVI 007, Dose A
n=12 Participants
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
|
Experimental: CIVI 007, Dose B
n=13 Participants
SC injection of PCSK9 inhibitor- dose titration
|
Experimental: CIVI 007, Dose C
n=12 Participants
SC injection of PCSK9 inhibitor- high dose given twice
|
|---|---|---|---|---|
|
Assessment of the Lipid Efficacy of CIVI 007
Day 29
|
-0.86 percentage change from baseline
Interval -38.3 to 31.3
|
-52.37 percentage change from baseline
Interval -88.7 to -24.8
|
-56.44 percentage change from baseline
Interval -74.5 to -20.9
|
-51.70 percentage change from baseline
Interval -83.5 to -24.5
|
|
Assessment of the Lipid Efficacy of CIVI 007
Day 57
|
-10.85 percentage change from baseline
Interval -57.2 to 42.2
|
-51.21 percentage change from baseline
Interval -71.8 to 27.3
|
-61.18 percentage change from baseline
Interval -82.0 to -14.3
|
-59.18 percentage change from baseline
Interval -82.4 to 1.0
|
|
Assessment of the Lipid Efficacy of CIVI 007
Day 85
|
-10.08 percentage change from baseline
Interval -52.4 to 42.2
|
-29.66 percentage change from baseline
Interval -51.9 to 5.7
|
-48.65 percentage change from baseline
Interval -59.1 to 3.3
|
-43.51 percentage change from baseline
Interval -57.1 to 32.7
|
SECONDARY outcome
Timeframe: Baseline through 2 month follow-upIncidence of any drug-related AEs
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo SC injection matching PCSK9 inhibitor given twice
|
Experimental: CIVI 007, Dose A
n=12 Participants
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
|
Experimental: CIVI 007, Dose B
n=13 Participants
SC injection of PCSK9 inhibitor- dose titration
|
Experimental: CIVI 007, Dose C
n=12 Participants
SC injection of PCSK9 inhibitor- high dose given twice
|
|---|---|---|---|---|
|
Assessment of CIVI 007 Adverse Events (AEs)
Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of CIVI 007 Adverse Events (AEs)
Mild
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Assessment of CIVI 007 Adverse Events (AEs)
Moderate
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
CIVI 007, Dose A
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
CIVI 007, Dose B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
CIVI 007, Dose C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CIVI 007, Dose A
n=12 participants at risk
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose B
n=13 participants at risk
SC injection of PCSK9 inhibitor- dose titration
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose C
n=12 participants at risk
SC injection of PCSK9 inhibitor- high dose given twice
CIVI 007: hypercholesterolemia agent
|
Placebo
n=12 participants at risk
Placebo SC injection matching PCSK9 inhibitor given twice
CIVI 007: hypercholesterolemia agent
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
Other adverse events
| Measure |
CIVI 007, Dose A
n=12 participants at risk
Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose B
n=13 participants at risk
SC injection of PCSK9 inhibitor- dose titration
CIVI 007: hypercholesterolemia agent
|
CIVI 007, Dose C
n=12 participants at risk
SC injection of PCSK9 inhibitor- high dose given twice
CIVI 007: hypercholesterolemia agent
|
Placebo
n=12 participants at risk
Placebo SC injection matching PCSK9 inhibitor given twice
CIVI 007: hypercholesterolemia agent
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 3 • Approximately 31 weeks.
|
15.4%
2/13 • Number of events 2 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 3 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Transaminases increased
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Investigations
Crystal urine present
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Protein total increased
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
4/12 • Number of events 4 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
23.1%
3/13 • Number of events 6 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
General disorders
Injection site induration
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 2 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Approximately 31 weeks.
|
15.4%
2/13 • Number of events 2 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Gingival pain
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • Approximately 31 weeks.
|
23.1%
3/13 • Number of events 3 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/12 • Approximately 31 weeks.
|
15.4%
2/13 • Number of events 2 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 2 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/13 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
8.3%
1/12 • Number of events 1 • Approximately 31 weeks.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/12 • Approximately 31 weeks.
|
7.7%
1/13 • Number of events 1 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
0.00%
0/12 • Approximately 31 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place