Trial Outcomes & Findings for Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus (NCT NCT01405196)
NCT ID: NCT01405196
Last Updated: 2017-12-19
Results Overview
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(\>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than \[\<\] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PhGA: assesses worsening in participant's general health status(range: 0\[none\] to 3\[severe\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Week 24
Results posted on
2017-12-19
Participant Flow
Due to safety reason, dosing in 200 mg reporting arm was prematurely terminated and the participants were discontinued from it. Therefore, the statistical analysis plan was amended after it and 200 mg reporting arm was not included in efficacy data analysis.
Participant milestones
| Measure |
PF-04236921 10 Milligram (10 mg)
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 200 mg
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
46
|
45
|
|
Overall Study
COMPLETED
|
34
|
35
|
23
|
36
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
23
|
9
|
Reasons for withdrawal
| Measure |
PF-04236921 10 Milligram (10 mg)
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 200 mg
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
9
|
0
|
|
Overall Study
Other
|
2
|
2
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
3
|
6
|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
3
|
1
|
Baseline Characteristics
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 200 mg
n=46 Participants
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.9 Years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
38.3 Years
STANDARD_DEVIATION 10.49 • n=7 Participants
|
41.3 Years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 13.04 • n=4 Participants
|
40.4 Years
STANDARD_DEVIATION 11.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(\>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than \[\<\] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PhGA: assesses worsening in participant's general health status(range: 0\[none\] to 3\[severe\]).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=35 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=36 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=42 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
|
59.9 Percentage of participants
|
39.2 Percentage of participants
|
40.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: \>=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (\<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A \[severe\] to E \[no disease\]). PhGA: assesses worsening in participant's general health status(range: 0\[none\] to 3\[severe\]).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Week 4
|
12.2 Percentage of participants
|
7.1 Percentage of participants
|
4.8 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Week 8
|
26.8 Percentage of participants
|
21.5 Percentage of participants
|
26.3 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Week 12
|
33.7 Percentage of participants
|
20 Percentage of participants
|
36.3 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Week 16
|
48.9 Percentage of participants
|
28.9 Percentage of participants
|
37.1 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Week 20
|
54.7 Percentage of participants
|
36.8 Percentage of participants
|
38.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: \>=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (\<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A \[severe\] to E \[no disease\]). PhGA: assesses worsening in participant's general health status (range: 0\[none\] to 3\[severe\]).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 4
|
9.5 Percentage of participants
|
7 Percentage of participants
|
9.2 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 8
|
23.8 Percentage of participants
|
25.7 Percentage of participants
|
30.2 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 12
|
35.6 Percentage of participants
|
24.9 Percentage of participants
|
42.6 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 16
|
50.2 Percentage of participants
|
34 Percentage of participants
|
41 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 20
|
56.5 Percentage of participants
|
46.9 Percentage of participants
|
42.2 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Week 24
|
61.2 Percentage of participants
|
41.4 Percentage of participants
|
41.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =\<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (\<10 percent \[%\] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0\[none\] to 3\[severe\]).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 4
|
26.2 Percentage of participants
|
21.7 Percentage of participants
|
21 Percentage of participants
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 8
|
26.2 Percentage of participants
|
29 Percentage of participants
|
30.6 Percentage of participants
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 12
|
33.6 Percentage of participants
|
39.6 Percentage of participants
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 16
|
45.5 Percentage of participants
|
39.2 Percentage of participants
|
26.2 Percentage of participants
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 20
|
43.7 Percentage of participants
|
31.6 Percentage of participants
|
21.7 Percentage of participants
|
—
|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Week 24
|
49.7 Percentage of participants
|
40.5 Percentage of participants
|
25.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: \>=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(\<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A\[severe\] to E \[no disease\]). PhGA: assesses worsening in participant's general health status (range: 0\[none\] to 3\[severe\]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=34 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=36 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=41 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
4 or More Points Reduction in SLEDAI Score
|
60.7 Percentage of participants
|
44.9 Percentage of participants
|
49.3 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
No New 1A/2B BILAG
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
90.2 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
No Worsening in PhGA
|
97.4 Percentage of participants
|
97.5 Percentage of participants
|
93.1 Percentage of participants
|
—
|
|
Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
Treatment Failure
|
0 Percentage of participants
|
2.8 Percentage of participants
|
4.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) \[\>5.0 - 10.0\*Upper limit of normal range (ULN)\], Albumin \[\<26-20 gram per liter (g/L)/ \<20 g/L\], Amylase \[\>2.0 - 5.0\*ULN\], Aspartate Aminotransferase (AST) \[\>5.0 - 10.0\*ULN\], Creatine Kinase (CK) \[\>5.0 - 10.0\* ULN/ \>10.0\*ULN\], Glucose (Hyperglycemia) \[\>13.9 - 27.8 millimoles/liter (mmol/L)\], Hemoglobin (HGB) \[\<80 - 65 g/L/ \<65 g/L\], Lipase \[\>2.0 - 5.0\*ULN\], Lymphocytes (Lymph.)(Absolute \[Abs\]) \[\<0.5 - 0.2\*10\^3/microliter (UL)/ \<0.2\*10\^3/UL\], Platelets \[\<50-25\*10\^3/UL/ \<25\*10\^3/UL\], potassium (low) \[\<3.0 - 2.5 mmol/L\], Sodium (low) \[\<130 - 120 mmol/L\], Total Neutrophils (TN) (Abs) \[\<1.0 - 0.5\*10\^3/UL/ \<0.5\*10\^3/UL\], Triglycerides \[\>5.7 - 11.4 mmol/L\], White Blood Cell Count (WBC) \[\<2.0 - 1.0\*10\^3/UL/ \<1.0\*10\^3/UL\].
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Tests Results
ALT
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Albumin: <26-20 g/L
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Albumin: < 20 g/L
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Amylase
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
AST
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
CK: >5.0 -10.0*ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
CK >10.0*ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Glucose (Hyperglycemia)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
HGB: <80 - 65 g/L
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
HGB: <65 g/L
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Lipase
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Lymph.(Abs)<0.5-0.2* 10^3/UL
|
6 Participants
|
9 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Lymph.(Abs) <0.2*10^3/UL
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Platelets <50 - 25*10^3/UL
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Platelets <25*10^3/UL
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Potassium (low)
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Sodium (low)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
TN (Abs)<1.0-0.5*10^3/UL
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
TN (Abs) <0.5*10^3/UL
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
Triglycerides
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
WBC <2.0 - 1.0*10^3/UL
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Tests Results
WBC <1.0*10^3/UL
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product.
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. Number of participants who discontinued due to adverse events were reported.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Due to Adverse Events
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product.
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. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
34 Participants
|
36 Participants
|
38 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
4 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product.
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. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Infectious AEs
|
25 Participants
|
28 Participants
|
25 Participants
|
26 Participants
|
|
Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Infectious SAEs
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product. Here, N (Number of participants analyzed) signifies participants evaluable for this outcome measure for each group respectively.
Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate \<=40 beats per minute (bpm) or \>=120 bpm; PR interval \>=220 millisecond (msec); QT interval \>=480 msec; QRS interval \>=120 msec; QT interval corrected using the Fridericia formula (QTcF) \>=500msec; no sinus rhythm.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=42 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=46 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=44 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=44 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Heart Rate <=40 beats/min or >=120 beats/min
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
PR Interval >=200 msec
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
QT Interval >=480 msec
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
QRS Interval >=120 msec
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
QTcF >=500 msec
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Rhythm (Not Sinus Rhythm)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product.
Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline \>=20 millimeter of mercury (mm Hg) and \>=160 mm Hg or a decrease from baseline \>=20 mm Hg and \<=90 mm Hg) and sitting diastolic blood pressure (increase from baseline \>=15 mm Hg and \>=90 mm Hg or decrease from baseline \>=15 mm Hg and \<=60 mm Hg), pulse rate (increase from baseline \>=15 beats/min and \>=120 beats/min or decrease from baseline \>=15 beats/min and \<=50 beats /min), body temperature (increase of \>=2 degree Fahrenheit (F) and temperature \>=101 degree F) and weight (change of \>=7% in body weight)
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Vital Signs Findings
Sitting Systolic Blood Pressure
|
8 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Important Vital Signs Findings
Sitting Diastolic Blood Pressure
|
14 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants With Potentially Clinically Important Vital Signs Findings
Sitting Pulse Rate
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Important Vital Signs Findings
Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Important Vital Signs Findings
Weight
|
12 Participants
|
23 Participants
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: Safety population defined as all participants who had at least one dose of investigational product.
Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Anti-drug Antibodies
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24Population: Pharmacokinetic analysis set was the subset of participants from safety analysis set (all participants who received at least 1 dose of investigational product) who provided at least 1 pharmacokinetic concentration. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Serum PF-04236921 concentrations over time were summarized.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=46 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Serum Concentration of PF-04236921
Day 1
|
26.3 nanogram per milliliter (ng/mL)
Standard Deviation 110.8
|
31.0 nanogram per milliliter (ng/mL)
Standard Deviation 146.9
|
15.2 nanogram per milliliter (ng/mL)
Standard Deviation 99.8
|
—
|
|
Serum Concentration of PF-04236921
Week 2
|
1297 nanogram per milliliter (ng/mL)
Standard Deviation 759.4
|
5640 nanogram per milliliter (ng/mL)
Standard Deviation 2274.0
|
22780 nanogram per milliliter (ng/mL)
Standard Deviation 9896.0
|
—
|
|
Serum Concentration of PF-04236921
Week 4
|
991.8 nanogram per milliliter (ng/mL)
Standard Deviation 527.6
|
4337 nanogram per milliliter (ng/mL)
Standard Deviation 1495.0
|
17550 nanogram per milliliter (ng/mL)
Standard Deviation 5757.1
|
—
|
|
Serum Concentration of PF-04236921
Week 6
|
608.4 nanogram per milliliter (ng/mL)
Standard Deviation 330.1
|
3396 nanogram per milliliter (ng/mL)
Standard Deviation 1410.0
|
13460 nanogram per milliliter (ng/mL)
Standard Deviation 5416.6
|
—
|
|
Serum Concentration of PF-04236921
Week 8
|
463.4 nanogram per milliliter (ng/mL)
Standard Deviation 254.9
|
2709 nanogram per milliliter (ng/mL)
Standard Deviation 1317.5
|
11110 nanogram per milliliter (ng/mL)
Standard Deviation 5023.7
|
—
|
|
Serum Concentration of PF-04236921
Week 12
|
1210 nanogram per milliliter (ng/mL)
Standard Deviation 607.0
|
6482 nanogram per milliliter (ng/mL)
Standard Deviation 2487.4
|
25240 nanogram per milliliter (ng/mL)
Standard Deviation 8114.0
|
—
|
|
Serum Concentration of PF-04236921
Week 16
|
703.2 nanogram per milliliter (ng/mL)
Standard Deviation 407.4
|
3886 nanogram per milliliter (ng/mL)
Standard Deviation 1322.1
|
16990 nanogram per milliliter (ng/mL)
Standard Deviation 6203.4
|
—
|
|
Serum Concentration of PF-04236921
Week 20
|
1452 nanogram per milliliter (ng/mL)
Standard Deviation 726.8
|
6978 nanogram per milliliter (ng/mL)
Standard Deviation 2954.0
|
31050 nanogram per milliliter (ng/mL)
Standard Deviation 11368
|
—
|
|
Serum Concentration of PF-04236921
Week 24
|
871.9 nanogram per milliliter (ng/mL)
Standard Deviation 450.4
|
4417 nanogram per milliliter (ng/mL)
Standard Deviation 2402.4
|
20150 nanogram per milliliter (ng/mL)
Standard Deviation 12091
|
—
|
SECONDARY outcome
Timeframe: Week 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoints. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=15 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=24 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=23 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Week 12
|
13.3 Percentage of Participants
|
20.8 Percentage of Participants
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Week 16
|
20.0 Percentage of Participants
|
25.0 Percentage of Participants
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Week 20
|
26.7 Percentage of Participants
|
25.0 Percentage of Participants
|
8.7 Percentage of Participants
|
—
|
|
Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Week 24
|
26.7 Percentage of Participants
|
20.8 Percentage of Participants
|
8.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Consistent with the protocol which pre-specified that if the number of participants with abnormal serological activity at baseline were \<25% of overall population, data for this outcome measure was not available.
Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Patient Global Visual Analog Scale (VAS) Scores at Baseline
|
50.44 mm
Standard Error 2.865
|
47.70 mm
Standard Error 2.880
|
49.47 mm
Standard Error 3.349
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 12
|
-9.21 mm
Interval -15.07 to -3.36
|
-4.20 mm
Interval -9.88 to 1.49
|
-6.88 mm
Interval -12.67 to -1.1
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 16
|
-8.75 mm
Interval -14.6 to -2.89
|
-10.20 mm
Interval -15.88 to -4.51
|
-5.99 mm
Interval -11.78 to -0.21
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 24
|
-9.17 mm
Interval -15.02 to -3.32
|
-7.45 mm
Interval -13.14 to -1.77
|
-10.64 mm
Interval -16.42 to -4.85
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 2
|
-9.17 mm
Interval -15.09 to -3.26
|
-1.54 mm
Interval -7.22 to 4.15
|
-3.58 mm
Interval -9.49 to 2.34
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 4
|
-3.24 mm
Interval -9.09 to 2.62
|
-4.01 mm
Interval -9.69 to 1.68
|
-1.24 mm
Interval -7.02 to 4.55
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 6
|
-5.48 mm
Interval -11.33 to 0.37
|
-3.62 mm
Interval -9.31 to 2.06
|
-7.24 mm
Interval -13.02 to -1.45
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 8
|
-4.17 mm
Interval -10.02 to 1.68
|
-6.03 mm
Interval -11.71 to -0.34
|
-7.11 mm
Interval -12.89 to -1.32
|
—
|
|
Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Week 20
|
-11.52 mm
Interval -17.38 to -5.67
|
-9.03 mm
Interval -14.71 to -3.34
|
-6.77 mm
Interval -12.56 to -0.99
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 4
|
3.17 Units on a scale
Interval -2.21 to 8.54
|
1.45 Units on a scale
Interval -3.72 to 6.62
|
-0.47 Units on a scale
Interval -5.66 to 4.73
|
—
|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 8
|
5.00 Units on a scale
Interval -0.37 to 10.38
|
2.82 Units on a scale
Interval -2.28 to 7.93
|
7.02 Units on a scale
Interval 1.83 to 12.22
|
—
|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 12
|
7.47 Units on a scale
Interval 2.09 to 12.85
|
2.51 Units on a scale
Interval -2.6 to 7.61
|
4.85 Units on a scale
Interval -0.35 to 10.04
|
—
|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 16
|
6.84 Units on a scale
Interval 1.47 to 12.22
|
6.65 Units on a scale
Interval 1.55 to 11.76
|
5.16 Units on a scale
Interval -0.04 to 10.35
|
—
|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 20
|
9.68 Units on a scale
Interval 4.3 to 15.05
|
5.19 Units on a scale
Interval 0.08 to 10.29
|
5.09 Units on a scale
Interval -0.1 to 10.28
|
—
|
|
Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Week 24
|
9.33 Units on a scale
Interval 3.95 to 14.71
|
5.04 Units on a scale
Interval -0.07 to 10.14
|
5.38 Units on a scale
Interval 0.18 to 10.57
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoint. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=43 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=46 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
MCS
|
39.50 Units on a scale
Standard Error 1.810
|
42.36 Units on a scale
Standard Error 1.426
|
39.94 Units on a scale
Standard Error 1.450
|
—
|
|
Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
PCS
|
33.47 Units on a scale
Standard Error 1.169
|
34.36 Units on a scale
Standard Error 1.250
|
34.64 Units on a scale
Standard Error 1.523
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 4
|
1.97 Units on a scale
Interval -0.69 to 4.64
|
1.45 Units on a scale
Interval -1.14 to 4.04
|
1.45 Units on a scale
Interval -1.12 to 4.02
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 8
|
1.57 Units on a scale
Interval -1.1 to 4.23
|
1.97 Units on a scale
Interval -0.59 to 4.52
|
2.05 Units on a scale
Interval -0.52 to 4.62
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 12
|
3.80 Units on a scale
Interval 1.13 to 6.46
|
2.50 Units on a scale
Interval -0.06 to 5.05
|
2.52 Units on a scale
Interval -0.05 to 5.09
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 16
|
4.73 Units on a scale
Interval 2.07 to 7.4
|
2.79 Units on a scale
Interval 0.24 to 5.35
|
2.95 Units on a scale
Interval 0.38 to 5.52
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 20
|
4.49 Units on a scale
Interval 1.82 to 7.15
|
1.71 Units on a scale
Interval -0.85 to 4.26
|
3.28 Units on a scale
Interval 0.71 to 5.85
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
MCS: Week 24
|
2.94 Units on a scale
Interval 0.28 to 5.6
|
2.14 Units on a scale
Interval -0.41 to 4.7
|
2.85 Units on a scale
Interval 0.28 to 5.42
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 4
|
3.95 Units on a scale
Interval 1.75 to 6.15
|
3.24 Units on a scale
Interval 1.1 to 5.38
|
1.28 Units on a scale
Interval -0.85 to 3.4
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 8
|
5.48 Units on a scale
Interval 3.27 to 7.68
|
4.79 Units on a scale
Interval 2.68 to 6.9
|
2.11 Units on a scale
Interval -0.01 to 4.23
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 12
|
6.06 Units on a scale
Interval 3.86 to 8.26
|
4.66 Units on a scale
Interval 2.55 to 6.77
|
2.82 Units on a scale
Interval 0.7 to 4.95
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 16
|
6.25 Units on a scale
Interval 4.05 to 8.45
|
4.50 Units on a scale
Interval 2.39 to 6.61
|
2.48 Units on a scale
Interval 0.36 to 4.6
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 20
|
6.39 Units on a scale
Interval 4.19 to 8.59
|
5.63 Units on a scale
Interval 3.52 to 7.74
|
3.29 Units on a scale
Interval 1.17 to 5.42
|
—
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
PCS: Week 24
|
5.98 Units on a scale
Interval 3.77 to 8.18
|
5.53 Units on a scale
Interval 3.42 to 7.64
|
2.94 Units on a scale
Interval 0.82 to 5.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 4
|
3.92 Units on a scale
Interval -2.0 to 9.83
|
4.78 Units on a scale
Interval -0.97 to 10.52
|
3.45 Units on a scale
Interval -2.27 to 9.16
|
—
|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 8
|
6.53 Units on a scale
Interval 0.62 to 12.45
|
6.55 Units on a scale
Interval 0.87 to 12.23
|
2.61 Units on a scale
Interval -3.1 to 8.33
|
—
|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 12
|
10.75 Units on a scale
Interval 4.83 to 16.66
|
6.41 Units on a scale
Interval 0.74 to 12.09
|
7.19 Units on a scale
Interval 1.48 to 12.91
|
—
|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 16
|
10.60 Units on a scale
Interval 4.69 to 16.52
|
6.41 Units on a scale
Interval 0.74 to 12.09
|
2.75 Units on a scale
Interval -2.97 to 8.46
|
—
|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 20
|
11.91 Units on a scale
Interval 5.99 to 17.82
|
7.78 Units on a scale
Interval 2.1 to 13.45
|
4.79 Units on a scale
Interval -0.93 to 10.5
|
—
|
|
Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Week 24
|
9.58 Units on a scale
Interval 3.66 to 15.49
|
6.69 Units on a scale
Interval 1.01 to 12.37
|
5.25 Units on a scale
Interval -0.47 to 10.96
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 16
|
4.73 Units on a scale
Interval 2.07 to 7.4
|
2.79 Units on a scale
Interval 0.24 to 5.35
|
2.95 Units on a scale
Interval 0.38 to 5.52
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 24
|
5.98 Units on a scale
Interval 3.77 to 8.18
|
5.53 Units on a scale
Interval 3.42 to 7.64
|
2.94 Units on a scale
Interval 0.82 to 5.06
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 4
|
3.95 Units on a scale
Interval 1.75 to 6.15
|
3.24 Units on a scale
Interval 1.1 to 5.38
|
1.28 Units on a scale
Interval -0.85 to 3.4
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 8
|
5.48 Units on a scale
Interval 3.27 to 7.68
|
4.79 Units on a scale
Interval 2.68 to 6.9
|
2.11 Units on a scale
Interval -0.01 to 4.23
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 12
|
6.06 Units on a scale
Interval 3.86 to 8.26
|
4.66 Units on a scale
Interval 2.55 to 6.77
|
2.82 Units on a scale
Interval 0.7 to 4.95
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 16
|
6.25 Units on a scale
Interval 4.05 to 8.45
|
4.50 Units on a scale
Interval 2.39 to 6.61
|
2.48 Units on a scale
Interval 0.36 to 4.6
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
PCS: Week 20
|
6.39 Units on a scale
Interval 4.19 to 8.59
|
5.63 Units on a scale
Interval 3.52 to 7.74
|
3.29 Units on a scale
Interval 1.17 to 5.42
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 4
|
1.97 Units on a scale
Interval -0.69 to 4.64
|
1.45 Units on a scale
Interval -1.14 to 4.04
|
1.45 Units on a scale
Interval -1.12 to 4.02
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 8
|
1.57 Units on a scale
Interval -1.1 to 4.23
|
1.97 Units on a scale
Interval -0.59 to 4.52
|
2.05 Units on a scale
Interval -0.52 to 4.62
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 12
|
3.80 Units on a scale
Interval 1.13 to 6.46
|
2.50 Units on a scale
Interval -0.06 to 5.05
|
2.52 Units on a scale
Interval -0.05 to 5.09
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 20
|
4.49 Units on a scale
Interval 1.82 to 7.15
|
1.71 Units on a scale
Interval -0.85 to 4.26
|
3.28 Units on a scale
Interval 0.71 to 5.85
|
—
|
|
Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
MCS: Week 24
|
2.94 Units on a scale
Interval 0.28 to 5.6
|
2.14 Units on a scale
Interval -0.41 to 4.7
|
2.85 Units on a scale
Interval 0.28 to 5.42
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline
|
25.91 Units on a scale
Standard Deviation 1.700
|
29.38 Units on a scale
Standard Deviation 1.506
|
25.96 Units on a scale
Standard Deviation 1.760
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis.
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.
Outcome measures
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 Participants
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 Participants
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 Participants
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 4
|
3.16 Units on a scale
Interval 0.25 to 6.07
|
2.77 Units on a scale
Interval -0.05 to 5.6
|
1.08 Units on a scale
Interval -1.72 to 3.89
|
—
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 8
|
4.39 Units on a scale
Interval 1.49 to 7.3
|
3.41 Units on a scale
Interval 0.62 to 6.2
|
2.44 Units on a scale
Interval -0.37 to 5.24
|
—
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 12
|
5.07 Units on a scale
Interval 2.16 to 7.97
|
3.59 Units on a scale
Interval 0.8 to 6.38
|
2.26 Units on a scale
Interval -0.54 to 5.06
|
—
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 16
|
5.81 Units on a scale
Interval 2.9 to 8.72
|
5.53 Units on a scale
Interval 2.74 to 8.32
|
1.93 Units on a scale
Interval -0.88 to 4.73
|
—
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 20
|
5.37 Units on a scale
Interval 2.46 to 8.28
|
4.32 Units on a scale
Interval 1.53 to 7.11
|
3.42 Units on a scale
Interval 0.61 to 6.22
|
—
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24
Week 24
|
4.39 Units on a scale
Interval 1.49 to 7.3
|
3.30 Units on a scale
Interval 0.51 to 6.09
|
2.70 Units on a scale
Interval -0.1 to 5.51
|
—
|
Adverse Events
PF-04236921 10 Milligram (10 mg)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
PF-04236921 50 mg
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
PF-04236921 200 mg
Serious events: 7 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 participants at risk
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 participants at risk
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 200 mg
n=46 participants at risk
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 participants at risk
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Investigations
Arthroscopy
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Immune system disorders
Drug hypersensitivity
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Cardiac disorders
Cardio
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Eye disorders
Visual impairment
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
General disorders
Pyrexia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Infectious mononucleosis
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Localised infection
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
Other adverse events
| Measure |
PF-04236921 10 Milligram (10 mg)
n=45 participants at risk
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 50 mg
n=47 participants at risk
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
PF-04236921 200 mg
n=46 participants at risk
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
Placebo
n=45 participants at risk
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
10.9%
5/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
11.1%
5/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.5%
4/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
13.0%
6/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
15.6%
7/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.5%
4/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.9%
4/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.7%
4/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
10.6%
5/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.7%
4/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Nervous system disorders
Headache
|
8.9%
4/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
17.0%
8/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
10.9%
5/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
General disorders
Injection site pain
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
General disorders
Pyrexia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.5%
4/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.7%
4/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Vascular disorders
Hypertension
|
8.9%
4/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.7%
4/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.1%
1/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Bronchitis
|
11.1%
5/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
12.8%
6/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.7%
3/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Pharyngitis
|
4.4%
2/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
4.3%
2/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.9%
4/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.4%
3/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
8.7%
4/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
0.00%
0/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
5/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
12.8%
6/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
23.9%
11/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
15.6%
7/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
|
Infections and infestations
Urinary tract infection
|
17.8%
8/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
10.6%
5/47
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
6.5%
3/46
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
15.6%
7/45
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER