Trial Outcomes & Findings for A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs (NCT NCT00810277)
NCT ID: NCT00810277
Last Updated: 2017-08-03
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
COMPLETED
PHASE3
14 participants
Baseline up to Week 24
2017-08-03
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Age, Continuous
|
53.86 years
STANDARD_DEVIATION 9.662 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Analysis population included all participants who entered the study.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
92.9 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*GH of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Disease Activity Score (DAS28)
DAS28 ESR: Baseline (n=14)
|
5.9896986 units on a scale
Standard Deviation 1.0636917
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 4 (n=14)
|
2.852859 units on a scale
Standard Deviation 1.3154333
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 8 (n=13)
|
2.1529895 units on a scale
Standard Deviation 1.0578132
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 12 (n=12)
|
1.9199257 units on a scale
Standard Deviation 0.9622713
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 16 (n=13)
|
1.6475303 units on a scale
Standard Deviation 1.205548
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 20 (n=13)
|
1.6527143 units on a scale
Standard Deviation 0.9999803
|
|
Disease Activity Score (DAS28)
DAS28 ESR: Week 24 (n=13)
|
1.977934 units on a scale
Standard Deviation 1.5634882
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Baseline (n=14)
|
5.7627144 units on a scale
Standard Deviation 0.9613441
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 4 (n=14)
|
3.3564332 units on a scale
Standard Deviation 1.2154714
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 8 (n=13)
|
2.684394 units on a scale
Standard Deviation 0.9556779
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 12 (n=12)
|
2.5826295 units on a scale
Standard Deviation 1.0084694
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 16 (n=13)
|
2.3791197 units on a scale
Standard Deviation 1.0837377
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 20 (n=13)
|
2.2859272 units on a scale
Standard Deviation 1.0212892
|
|
Disease Activity Score (DAS28)
DAS28 CRP: Week 24 (n=13)
|
2.3343281 units on a scale
Standard Deviation 1.2686423
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*GH of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 16 (n=13)
|
61.54 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 4 (n=14)
|
42.86 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 8 (n=13)
|
69.23 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 12 (n=12)
|
83.33 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 16 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 20 (n=13)
|
84.62 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 ESR: Week 24 (n=13)
|
69.23 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 4 (n=14)
|
35.71 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 8 (n=13)
|
46.15 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 12 (n=12)
|
41.67 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 20 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
DAS28 CRP: Week 24 (n=13)
|
61.54 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
ACR20, ACR50, and ACR70 response: greater than or equal to (\>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 16 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 20 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 24 (n=13)
|
61.54 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 4 (n=14)
|
0.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 8 (n=13)
|
46.15 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 12 (n=13)
|
30.77 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 16 (n=13)
|
46.15 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 20 (n=13)
|
53.85 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR70: Week 24 (n=13)
|
61.54 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 4 (n=14)
|
57.14 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 8 (n=13)
|
100.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 12 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 16 (n=13)
|
100.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 20 (n=13)
|
84.62 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR20: Week 24 (n=13)
|
100.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 4 (n=14)
|
28.57 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 8 (n=13)
|
76.92 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
ACR50: Week 12 (n=13)
|
61.54 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
C-Reactive Protein (CRP) Level
Baseline (n=14)
|
35.81 milligram per liter (mg/L)
Standard Deviation 19.459
|
|
C-Reactive Protein (CRP) Level
Week 4 (n=14)
|
1.29 milligram per liter (mg/L)
Standard Deviation 0.994
|
|
C-Reactive Protein (CRP) Level
Week 24 (n=13)
|
2.96 milligram per liter (mg/L)
Standard Deviation 3.577
|
|
C-Reactive Protein (CRP) Level
Week 8 (n=13)
|
1.43 milligram per liter (mg/L)
Standard Deviation 0.910
|
|
C-Reactive Protein (CRP) Level
Week 12 (n=12)
|
1.16 milligram per liter (mg/L)
Standard Deviation 0.700
|
|
C-Reactive Protein (CRP) Level
Week 16 (n=13)
|
2.42 milligram per liter (mg/L)
Standard Deviation 3.486
|
|
C-Reactive Protein (CRP) Level
Week 20 (n=13)
|
1.10 milligram per liter (mg/L)
Standard Deviation 0.648
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Baseline (n=14)
|
37.14 millimeter per hour (mm/h)
Standard Deviation 18.102
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 4 (n=14)
|
3.71 millimeter per hour (mm/h)
Standard Deviation 3.832
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 8 (n=13)
|
4.85 millimeter per hour (mm/h)
Standard Deviation 8.543
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 12 (n=12)
|
2.42 millimeter per hour (mm/h)
Standard Deviation 0.996
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 16 (n=13)
|
3.00 millimeter per hour (mm/h)
Standard Deviation 2.677
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 20 (n=13)
|
2.46 millimeter per hour (mm/h)
Standard Deviation 1.050
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 24 (n=13)
|
6.46 millimeter per hour (mm/h)
Standard Deviation 7.666
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis population included all participants who entered the study.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants Who Discontinued the Study
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Analysis population included all participants who entered the study.
Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal
>1.5 ULN ALT
|
7.14 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal
>1.5 ULN AST
|
7.69 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who entered the study.
Low density lipoprotein (LDL) level was categorized as 'Optimal (less than \[\<\] 100 milligram per deciliter \[mg/dL\])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as 'Acceptable (40-59 mg/dL)', 'High (\>=60 mg/dL)'. Total cholesterol (TC) level was categorized as 'Desirable (\<200 mg/dL)', 'Borderline High (200-239 mg/dL)', 'High (\>=240 mg/dL)'.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Percentage of Participants With Lipid Level Elevations
LDL: Near Optimal/Above Optimal
|
30.77 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
LDL: Borderline High
|
38.46 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
LDL: High
|
15.38 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
LDL: Very high
|
0.00 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
HDL: Acceptable
|
30.77 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
TC: High
|
38.46 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
LDL: Optimal
|
15.38 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
HDL: High
|
69.23 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
TC: Desirable
|
30.77 percentage of participants
|
|
Percentage of Participants With Lipid Level Elevations
TC: Borderline High
|
30.77 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.
Outcome measures
| Measure |
Tocilizumab
n=14 Participants
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Neutrophil Count
Baseline (n=13)
|
5.53 E^9 per liter
Standard Deviation 1.849
|
|
Neutrophil Count
Week 4 (n=14)
|
2.31 E^9 per liter
Standard Deviation 0.971
|
|
Neutrophil Count
Week 8 (n=13)
|
2.32 E^9 per liter
Standard Deviation 1.059
|
|
Neutrophil Count
Week 12 (n=11)
|
2.12 E^9 per liter
Standard Deviation 0.675
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=14 participants at risk
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Infections and infestations
Erysipelas
|
7.1%
1/14 • Up to 24 weeks
|
Other adverse events
| Measure |
Tocilizumab
n=14 participants at risk
Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
21.4%
3/14 • Up to 24 weeks
|
|
Cardiac disorders
Arrhythmia
|
7.1%
1/14 • Up to 24 weeks
|
|
Eye disorders
Conjunctivitis
|
7.1%
1/14 • Up to 24 weeks
|
|
Eye disorders
Dry eye
|
7.1%
1/14 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Up to 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Up to 24 weeks
|
|
General disorders
Chest pain
|
7.1%
1/14 • Up to 24 weeks
|
|
General disorders
Influenza like illness
|
7.1%
1/14 • Up to 24 weeks
|
|
General disorders
Infusion related reaction
|
21.4%
3/14 • Up to 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
14.3%
2/14 • Up to 24 weeks
|
|
Infections and infestations
Laryngitis
|
7.1%
1/14 • Up to 24 weeks
|
|
Infections and infestations
Oral infection
|
7.1%
1/14 • Up to 24 weeks
|
|
Infections and infestations
Pharyngitis
|
7.1%
1/14 • Up to 24 weeks
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
2/14 • Up to 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14 • Up to 24 weeks
|
|
Infections and infestations
Viral infection
|
7.1%
1/14 • Up to 24 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.1%
1/14 • Up to 24 weeks
|
|
Investigations
Blood cholesterol increased
|
14.3%
2/14 • Up to 24 weeks
|
|
Investigations
Blood potassium decreased
|
7.1%
1/14 • Up to 24 weeks
|
|
Investigations
Hepatic enzyme increased
|
7.1%
1/14 • Up to 24 weeks
|
|
Investigations
Lipids increased
|
21.4%
3/14 • Up to 24 weeks
|
|
Investigations
Neutrophil count decreased
|
14.3%
2/14 • Up to 24 weeks
|
|
Investigations
Transaminases increased
|
7.1%
1/14 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
14.3%
2/14 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Up to 24 weeks
|
|
Nervous system disorders
Memory impairment
|
7.1%
1/14 • Up to 24 weeks
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Up to 24 weeks
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Up to 24 weeks
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
7.1%
1/14 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
7.1%
1/14 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Up to 24 weeks
|
|
Vascular disorders
Haematoma
|
7.1%
1/14 • Up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER