Trial Outcomes & Findings for Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. (NCT NCT03895801)
NCT ID: NCT03895801
Last Updated: 2022-08-25
Results Overview
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2022-08-25
Participant Flow
Participant milestones
| Measure |
IFX-1 + Placebo-GC
IFX-1: 800 mg intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Placebo-Glucocorticoid (Placebo-GC): orally administered daily
|
Placebo-IFX-1 + Standard Dose GC
Placebo-IFX-1: Placebo infusion intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Glucocorticoid (GC): starting dose of 60 mg daily orally administered, then tapered down
|
IFX-1 + Reduced Dose GC
IFX-1: 800 mg intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Glucocorticoid (GC): starting dose of 30 mg daily orally administered, then tapered down
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
24
|
15
|
|
Overall Study
COMPLETED
|
16
|
22
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
Baseline characteristics by cohort
| Measure |
IFX-1 + Placebo-GC
n=18 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=24 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=15 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
57 Participants
n=4 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
|
|
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
|
|
AAV disease type
Granulomatosis with polyangiitis (GPA)
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
AAV disease type
Microscopic polyangiitis (MPA)
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Full Analysis Set
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=18 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=23 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=13 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Percentage of Subjects Achieving Clinical Response
|
16 Participants
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=18 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=23 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=13 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Percentage of Subjects With Clinical Remission
|
14 Participants
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Full Analysis Set
Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=16 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=22 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=12 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Change From Baseline in BVASv3 Total Score
|
-13.8 score on a scale
Standard Deviation 4.1
|
-14.7 score on a scale
Standard Deviation 5.9
|
-16.6 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=16 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=22 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=12 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Vasculitis Damage Index (VDI)
|
1.0 score on a scale
Standard Deviation 1.0
|
1.5 score on a scale
Standard Deviation 1.1
|
1.9 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity;
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=16 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=22 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=12 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Physician Global Assessment (PGA)
|
0.4 score on a scale
Standard Deviation 1.0
|
0.1 score on a scale
Standard Deviation 0.5
|
0.7 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set
Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation: eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=16 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=22 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=12 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Estimated Glomerular Filtration Rate
|
50.2 mL/min/1.73 m²
Standard Deviation 17.7
|
57.0 mL/min/1.73 m²
Standard Deviation 22.8
|
51.2 mL/min/1.73 m²
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Analysis Set
Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE)
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=18 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=24 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=15 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)
|
16 Participants
|
24 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Safety Analysis Set (Data missing from 2 patients in IFX-1 + Placebo-GC group, from 2 patients in Placebo-IFX-1 + standard dose GC group, and from 3 patients in IFX-1 + reduced dose GC group)
Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in "Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis." by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=16 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=22 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=12 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Glucocorticoid Toxicity Index (GTI)
|
0.8 score on a scale
Standard Deviation 9.0
|
44.9 score on a scale
Standard Deviation 41.5
|
26.1 score on a scale
Standard Deviation 39.2
|
SECONDARY outcome
Timeframe: Week 16 (pre-dose)Population: Safety Analysis Set (Data missing from 5 patients in IFX-1 + Placebo-GC group, from 7 patients in Placebo-IFX-1 + standard dose GC group, and from 7 patients in IFX-1 + reduced dose GC group)
Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit.
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=13 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=17 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=8 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
IFX-1 Plasma Concentrations (Pre-dose)
|
67077.19 ng/mL
Geometric Coefficient of Variation 77.33
|
47.80 ng/mL
Geometric Coefficient of Variation 152.42
|
52597.85 ng/mL
Geometric Coefficient of Variation 118.15
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, from 10 patients in Placebo-IFX-1 + standard dose GC group, and from 8 patients in IFX-1 + reduced dose GC group)
Pharmacodynamics endpoint: Plasma concentrations of C5a
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=14 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=14 Participants
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=7 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Plasma Concentrations of C5a
|
10.6816 ng/mL
Standard Deviation 5.8505
|
39.2822 ng/mL
Standard Deviation 25.6249
|
13.6320 ng/mL
Standard Deviation 12.3040
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, and from 7 patients in IFX-1 + reduced dose GC group, IFX-1 blocking activity was not assessed for patients in Placebo-IFX-1 + standard dose GC group)
Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=14 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=8 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
IFX-1 Blocking Activity 10 nM
|
100.571 percentage of IFX-1 blocking activity
Standard Deviation 2.651
|
—
|
100.508 percentage of IFX-1 blocking activity
Standard Deviation 10.051
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, and from 7 patients in IFX-1 + reduced dose GC group, IFX-1 blocking activity was not assessed for patients in Placebo-IFX-1 + standard dose GC group)
Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM
Outcome measures
| Measure |
IFX-1 + Placebo-GC
n=14 Participants
IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=8 Participants
IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
IFX-1 Blocking Activity 2.5 nM
|
98.260 percentage of IFX-1 blocking activity
Standard Deviation 16.731
|
—
|
121.881 percentage of IFX-1 blocking activity
Standard Deviation 59.979
|
Adverse Events
IFX-1 + Placebo-GC
Serious events: 5 serious events
Other events: 15 other events
Deaths: 1 deaths
Placebo-IFX-1 + Standard Dose GC
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
IFX-1 + Reduced Dose GC
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IFX-1 + Placebo-GC
n=18 participants at risk
IFX-1: intravenously administered Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=24 participants at risk
Placebo-IFX-1: intravenously administered Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=15 participants at risk
IFX-1: intravenously administered Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
General disorders
Condition aggravated
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Malaise
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
Other adverse events
| Measure |
IFX-1 + Placebo-GC
n=18 participants at risk
IFX-1: intravenously administered Placebo-Glucocorticoid (Placebo-GC): orally administered
|
Placebo-IFX-1 + Standard Dose GC
n=24 participants at risk
Placebo-IFX-1: intravenously administered Glucocorticoid (GC): orally administered
|
IFX-1 + Reduced Dose GC
n=15 participants at risk
IFX-1: intravenously administered Glucocorticoid (GC): orally administered
|
|---|---|---|---|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
25.0%
6/24 • Number of events 7 • 24 weeks
|
33.3%
5/15 • Number of events 6 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • 24 weeks
|
12.5%
3/24 • Number of events 3 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Asymptomatic COVID-19
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Conjunctivitis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Pustule
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
25.0%
6/24 • Number of events 7 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Number of events 4 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
20.0%
3/15 • Number of events 4 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • 24 weeks
|
8.3%
2/24 • Number of events 4 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
General disorders
Fatigue
|
0.00%
0/18 • 24 weeks
|
16.7%
4/24 • Number of events 4 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
General disorders
Fat tissue increased
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
16.7%
4/24 • Number of events 5 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Adverse drug reaction
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
20.0%
3/15 • Number of events 3 • 24 weeks
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
General disorders
Chest pain
|
0.00%
0/18 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Condition aggravated
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Feeling cold
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
General disorders
Chills
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Feeling hot
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
General disorders
Infusion site extravasation
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
General disorders
Thirst
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
3/18 • Number of events 3 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
20.0%
3/15 • Number of events 3 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Gingivitis ulcerative
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
25.0%
6/24 • Number of events 7 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Vascular disorders
Haematoma
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Vascular disorders
Cyanosis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 2 • 24 weeks
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Vascular disorders
Vasculitis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Vascular disorders
White coat hypertension
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Fluid retention
|
16.7%
3/18 • Number of events 4 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 2 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • 24 weeks
|
20.8%
5/24 • Number of events 5 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Sleep disorder
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
16.7%
4/24 • Number of events 4 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/18 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Decreased interest
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Investigations
Weight increased
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
20.8%
5/24 • Number of events 5 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Investigations
Blood sodium increased
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Investigations
Cardiac murmur
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Investigations
Hepatic enzyme abnormal
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/18 • 24 weeks
|
16.7%
4/24 • Number of events 4 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
2/18 • Number of events 3 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • 24 weeks
|
8.3%
2/24 • Number of events 3 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
13.3%
2/15 • Number of events 2 • 24 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
5.6%
1/18 • Number of events 2 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Heavy exposure to ultraviolet light
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 2 • 24 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Atrial thrombosis
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Eye disorders
Corneal erosion
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Eye disorders
Dacryoadenitis acquired
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Renal and urinary disorders
Nocturia
|
11.1%
2/18 • Number of events 2 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/18 • 24 weeks
|
8.3%
2/24 • Number of events 2 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Immune system disorders
Secondary immunodeficiency
|
0.00%
0/18 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
6.7%
1/15 • Number of events 1 • 24 weeks
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/18 • 24 weeks
|
4.2%
1/24 • Number of events 1 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
|
Reproductive system and breast disorders
Gynaecomastia
|
5.6%
1/18 • Number of events 1 • 24 weeks
|
0.00%
0/24 • 24 weeks
|
0.00%
0/15 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place