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Trial record 1 of 1 for:    NCT01408576
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Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (EMBODY4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408576
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Intervention Drug: Epratuzumab
Enrollment 1250
Recruitment Details The study started to enroll patients in July 2011 and concluded in February 2016.
Pre-assignment Details Participant Flow refers to the Enrolled Set, that consisted of all subjects who gave informed consent.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)
Hide Arm/Group Description Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Period Title: Overall Study
Started 244 498 508
Completed 56 0 0
Not Completed 188 498 508
Reason Not Completed
Lack of Efficacy             17             30             48
Protocol Violation             1             2             2
Lost to Follow-up             10             9             17
Withdrawal by Subject             34             60             66
Sponsor terminated study             89             333             330
AE, serious fatal             4             4             1
SAE, non-fatal             11             23             14
AE, non-serious non-fatal             12             19             11
SAE, non-fatal+AE, non-serious non-fatal             0             1             1
AE, unknown type             0             1             0
Other             10             16             18
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) Total Title
Hide Arm/Group Description Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

 [Not Specified]
Overall Number of Baseline Participants 244 498 508 1250
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Enrolled Set, that consisted of all subjects who gave informed consent.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 498 participants 508 participants 1250 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
239
  98.0%
489
  98.2%
490
  96.5%
1218
  97.4%
>=65 years
5
   2.0%
9
   1.8%
18
   3.5%
32
   2.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 498 participants 508 participants 1250 participants
41.0  (12.0) 41.9  (11.5) 42.5  (11.9) 42.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 498 participants 508 participants 1250 participants
Female
226
  92.6%
467
  93.8%
478
  94.1%
1171
  93.7%
Male
18
   7.4%
31
   6.2%
30
   5.9%
79
   6.3%
1.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Hide Description A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame During the treatment period (through Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received more than (>) 0mL of study medication.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) All Epratuzumab 600 mg Per Week All Subjects
Hide Arm/Group Description:
Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2

600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 244 497 507 751 1248
Measure Type: Count of Participants
Unit of Measure: Participants
26
  10.7%
45
   9.1%
25
   4.9%
51
   6.8%
96
   7.7%
2.Primary Outcome
Title Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
Hide Description A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame During the treatment period (through Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Hide Arm/Group Description:
Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 244 497 507 751 1248
Measure Type: Number
Unit of Measure: percentage of participants
10.7 9.1 4.9 6.8 7.7
3.Primary Outcome
Title Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Hide Description

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

  • Death
  • Life-threatening
  • Significant or persistent disability/incapacity
  • Congenital anomaly/birth defect (including that occurring in a fetus)
  • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
  • Initial inpatient hospitalization or prolongation of hospitalization
Time Frame During the treatment period (through Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Hide Arm/Group Description:
Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 244 497 507 751 1248
Measure Type: Count of Participants
Unit of Measure: Participants
81
  33.2%
119
  23.9%
104
  20.5%
185
  24.6%
304
  24.4%
4.Primary Outcome
Title Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
Hide Description

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:

  • Death
  • Life-threatening
  • Significant or persistent disability/incapacity
  • Congenital anomaly/birth defect (including that occurring in a fetus)
  • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
  • Initial inpatient hospitalization or prolongation of hospitalization
Time Frame During the treatment period (through Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Hide Arm/Group Description:
Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 244 497 507 751 1248
Measure Type: Number
Unit of Measure: percentage of participants
33.2 23.9 20.5 24.6 24.4
5.Secondary Outcome
Title Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Hide Description Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1) All Epratuzumab 600 mg Per Week (FASS1) All Subjects (FASS1)
Hide Arm/Group Description:

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 230 488 494 724 1212
Measure Type: Count of Participants
Unit of Measure: Participants
82
  35.7%
146
  29.9%
134
  27.1%
216
  29.8%
362
  29.9%
6.Secondary Outcome
Title Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Hide Description Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1) All Epratuzumab 600 mg Per Week (FASS1) All Subjects (FASS1)
Hide Arm/Group Description:

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 230 488 494 724 1212
Measure Type: Number
Unit of Measure: percentage of participants
35.7 29.9 27.1 29.8 29.9
7.Secondary Outcome
Title Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Hide Description Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1) All Epratuzumab 600 mg Per Week (FASS1) All Subjects (FASS1)
Hide Arm/Group Description:

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 186 306 298 484 790
Measure Type: Count of Participants
Unit of Measure: Participants
74
  39.8%
66
  21.6%
78
  26.2%
152
  31.4%
218
  27.6%
8.Secondary Outcome
Title The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
Hide Description Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point.
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1) Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1) Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1) All Epratuzumab 600 mg Per Week (FASS1) All Subjects (FASS1)
Hide Arm/Group Description:

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365), or SL0010 (NCT01261793) prior to enrollment in SL0012.

Subjects were enrolled prior to the approval of Protocol Amendment 2. Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Overall Number of Participants Analyzed 186 306 298 484 790
Measure Type: Number
Unit of Measure: percentage of participants
39.8 21.6 26.2 31.4 27.6
Time Frame Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Hide Arm/Group Description Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
All-Cause Mortality
Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/244 (1.64%)      4/497 (0.80%)      1/507 (0.20%)      5/751 (0.67%)      9/1248 (0.72%)    
Hide Serious Adverse Events
Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   81/244 (33.20%)      119/497 (23.94%)      104/507 (20.51%)      185/751 (24.63%)      304/1248 (24.36%)    
Blood and lymphatic system disorders           
Anaemia * 1  1/244 (0.41%)  1 2/497 (0.40%)  2 1/507 (0.20%)  2 2/751 (0.27%)  3 4/1248 (0.32%)  5
Leukopenia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  2 2/751 (0.27%)  2 3/1248 (0.24%)  3
Neutropenia * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 1/507 (0.20%)  1 1/751 (0.13%)  1 3/1248 (0.24%)  3
Thrombocytopenia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  2 2/751 (0.27%)  2 3/1248 (0.24%)  3
Eosinophilia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Haemorrhagic diathesis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Lymphadenopathy * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Pancytopenia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Splenic cyst * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cardiac disorders           
Myocardial infarction * 1  2/244 (0.82%)  2 1/497 (0.20%)  1 0/507 (0.00%)  0 2/751 (0.27%)  2 3/1248 (0.24%)  3
Pericarditis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Acute myocardial infarction * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Angina pectoris * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Atrioventricular block complete * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Bradycardia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cardiac failure congestive * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Pleuropericarditis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Sinoatrial block * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Supraventricular tachycardia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  2 1/751 (0.13%)  2 1/1248 (0.08%)  2
Tachycardia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Cardiac arrest * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Congenital, familial and genetic disorders           
Factor VII deficiency * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Ear and labyrinth disorders           
Vertigo * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Endocrine disorders           
Adrenal insufficiency * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Toxic nodular goitre * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Eye disorders           
Cataract * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Amaurosis fugax * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Necrotising retinitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Panophthalmitis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Retinal disorder * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Gastrointestinal disorders           
Vomiting * 1  1/244 (0.41%)  2 3/497 (0.60%)  3 3/507 (0.59%)  3 4/751 (0.53%)  5 7/1248 (0.56%)  8
Diarrhoea * 1  0/244 (0.00%)  0 3/497 (0.60%)  3 3/507 (0.59%)  3 3/751 (0.40%)  3 6/1248 (0.48%)  6
Abdominal pain * 1  1/244 (0.41%)  1 3/497 (0.60%)  3 1/507 (0.20%)  1 2/751 (0.27%)  2 5/1248 (0.40%)  5
Nausea * 1  2/244 (0.82%)  3 1/497 (0.20%)  1 1/507 (0.20%)  1 3/751 (0.40%)  4 4/1248 (0.32%)  5
Pancreatitis * 1  0/244 (0.00%)  0 3/497 (0.60%)  3 1/507 (0.20%)  1 1/751 (0.13%)  1 4/1248 (0.32%)  4
Gastritis * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 1/507 (0.20%)  1 2/751 (0.27%)  2 3/1248 (0.24%)  3
Abdominal pain upper * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Dysphagia * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Pancreatitis acute * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  3 1/751 (0.13%)  3 2/1248 (0.16%)  4
Anal fissure * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Colitis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Colitis ischaemic * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Constipation * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Crohn's disease * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Eosinophilic colitis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Gastritis haemorrhagic * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Gastrointestinal haemorrhage * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Gastrooesophageal reflux disease * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hiatus hernia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Impaired gastric emptying * 1  0/244 (0.00%)  0 1/497 (0.20%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  2
Inflammatory bowel disease * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Intestinal obstruction * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Oedematous pancreatitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  2 1/751 (0.13%)  2 1/1248 (0.08%)  2
Oesophageal disorder * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Oesophageal motility disorder * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Oesophageal spasm * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Peptic ulcer * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Peritoneal haemorrhage * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Salivary gland calculus * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Subileus * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
General disorders           
Chest pain * 1  1/244 (0.41%)  1 4/497 (0.80%)  4 8/507 (1.58%)  9 9/751 (1.20%)  10 13/1248 (1.04%)  14
Non-cardiac chest pain * 1  2/244 (0.82%)  2 2/497 (0.40%)  2 0/507 (0.00%)  0 2/751 (0.27%)  2 4/1248 (0.32%)  4
Pyrexia * 1  1/244 (0.41%)  1 2/497 (0.40%)  2 1/507 (0.20%)  1 2/751 (0.27%)  2 4/1248 (0.32%)  4
Asthenia * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Drug interaction * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Drug intolerance * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hyperthermia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Impaired healing * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Local swelling * 1  1/244 (0.41%)  2 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  2 1/1248 (0.08%)  2
Oedema peripheral * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Serositis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hepatobiliary disorders           
Cholelithiasis * 1  2/244 (0.82%)  2 2/497 (0.40%)  2 0/507 (0.00%)  0 2/751 (0.27%)  2 4/1248 (0.32%)  4
Cholecystitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 3/507 (0.59%)  3 3/751 (0.40%)  3 3/1248 (0.24%)  3
Bile duct stone * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 2/507 (0.39%)  3 2/751 (0.27%)  3 2/1248 (0.16%)  3
Cholangitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cholecystitis acute * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Cholelithiasis migration * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Hepatic steatosis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Immune system disorders           
Drug hypersensitivity * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Anaphylactic reaction * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Infections and infestations           
Pneumonia * 1  6/244 (2.46%)  6 7/497 (1.41%)  7 9/507 (1.78%)  10 15/751 (2.00%)  16 22/1248 (1.76%)  23
Sepsis * 1  3/244 (1.23%)  4 3/497 (0.60%)  3 4/507 (0.79%)  4 7/751 (0.93%)  8 10/1248 (0.80%)  11
Cellulitis * 1  1/244 (0.41%)  1 4/497 (0.80%)  4 3/507 (0.59%)  5 4/751 (0.53%)  6 8/1248 (0.64%)  10
Gastroenteritis * 1  2/244 (0.82%)  2 3/497 (0.60%)  3 2/507 (0.39%)  2 4/751 (0.53%)  4 7/1248 (0.56%)  7
Arthritis bacterial * 1  1/244 (0.41%)  1 2/497 (0.40%)  3 0/507 (0.00%)  0 1/751 (0.13%)  1 3/1248 (0.24%)  4
Diverticulitis * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 1/507 (0.20%)  1 2/751 (0.27%)  2 3/1248 (0.24%)  3
Gastroenteritis salmonella * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 1/507 (0.20%)  1 2/751 (0.27%)  2 3/1248 (0.24%)  3
Influenza * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 1/507 (0.20%)  1 3/751 (0.40%)  3 3/1248 (0.24%)  3
Pyelonephritis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 2/507 (0.39%)  2 3/751 (0.40%)  3 3/1248 (0.24%)  3
Urinary tract infection * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  3 2/751 (0.27%)  3 3/1248 (0.24%)  4
Bronchitis * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Clostridium difficile colitis * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Clostridium difficile infection * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Meningitis viral * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Subcutaneous abscess * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Upper respiratory tract infection * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 2/507 (0.39%)  2 2/751 (0.27%)  2 2/1248 (0.16%)  2
Abscess * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Abscess limb * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Anal abscess * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Appendicitis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Bronchopneumonia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cystitis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Cytomegalovirus chorioretinitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cytomegalovirus infection * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Endocarditis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Epstein-Barr virus infection * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Escherichia bacteraemia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Escherichia sepsis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Gangrene * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
H1N1 influenza * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Haematoma infection * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hepatitis B * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Herpes zoster * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Lobar pneumonia * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Lower respiratory tract infection * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Meningitis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Meningitis aseptic * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Meningitis bacterial * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pelvic inflammatory disease * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Perineal abscess * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Pneumonia bacterial * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pneumonia legionella * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pneumonia streptococcal * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pyelonephritis acute * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Respiratory tract infection * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Salpingitis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Tooth abscess * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Injury, poisoning and procedural complications           
Meniscus injury * 1  3/244 (1.23%)  3 0/497 (0.00%)  0 0/507 (0.00%)  0 3/751 (0.40%)  3 3/1248 (0.24%)  3
Tendon rupture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  3 2/751 (0.27%)  3 3/1248 (0.24%)  4
Ankle fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Fibula fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Head injury * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Joint dislocation * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Laceration * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Radius fracture * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 0/507 (0.00%)  0 2/751 (0.27%)  2 2/1248 (0.16%)  2
Road traffic accident * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Sternal fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Wrist fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Accidental overdose * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Concussion * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Contusion * 1  0/244 (0.00%)  0 1/497 (0.20%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  2
Delayed recovery from anaesthesia * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Femoral neck fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Femur fracture * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hip fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Ligament rupture * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Lumbar vertebral fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Nail avulsion * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Overdose * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Post procedural complication * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Rib fracture * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Spinal column injury * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Spinal fracture * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Tendon injury * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Tibia fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Upper limb fracture * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Investigations           
Biopsy liver * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Blood cortisol decreased * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Electrocardiogram QT prolonged * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Transaminases increased * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Troponin increased * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Metabolism and nutrition disorders           
Dehydration * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  2 2/751 (0.27%)  2 3/1248 (0.24%)  3
Diabetes mellitus inadequate control * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hypoglycaemia * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Hypokalaemia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hyponatraemia * 1  0/244 (0.00%)  0 1/497 (0.20%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  2
Musculoskeletal and connective tissue disorders           
Systemic lupus erythematosus * 1  7/244 (2.87%)  7 13/497 (2.62%)  15 12/507 (2.37%)  12 19/751 (2.53%)  19 32/1248 (2.56%)  34
Osteoarthritis * 1  1/244 (0.41%)  1 2/497 (0.40%)  4 2/507 (0.39%)  2 3/751 (0.40%)  3 5/1248 (0.40%)  7
Arthralgia * 1  1/244 (0.41%)  1 2/497 (0.40%)  2 1/507 (0.20%)  1 2/751 (0.27%)  2 4/1248 (0.32%)  4
Arthritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 3/507 (0.59%)  3 3/751 (0.40%)  3 4/1248 (0.32%)  4
Osteonecrosis * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 1/507 (0.20%)  1 3/751 (0.40%)  3 3/1248 (0.24%)  3
Back pain * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Bursitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 2/507 (0.39%)  2 2/751 (0.27%)  2 2/1248 (0.16%)  2
Foot deformity * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  1 1/751 (0.13%)  1 2/1248 (0.16%)  2
Intervertebral disc disorder * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Intervertebral disc protrusion * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Chondromalacia * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Enthesopathy * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Fasciitis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Muscular weakness * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Myalgia * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Osteoporotic fracture * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pain in extremity * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Patellofemoral pain syndrome * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Periarthritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Rotator cuff syndrome * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
SLE arthritis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Soft tissue necrosis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Spinal osteoarthritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Spondylolisthesis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Synovial cyst * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Tenosynovitis stenosans * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous cell carcinoma of skin * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 2/507 (0.39%)  2 3/751 (0.40%)  3 3/1248 (0.24%)  3
Uterine leiomyoma * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Adenocarcinoma of colon * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Adenocarcinoma pancreas * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Bladder cancer * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Bowen's disease * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Breast cancer stage I * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Cervix carcinoma stage 0 * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Gastric cancer * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Myeloproliferative disorder * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Neuroendocrine carcinoma of the skin * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Ovarian adenoma * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Squamous cell carcinoma * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Nervous system disorders           
Headache * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 4/507 (0.79%)  5 4/751 (0.53%)  5 6/1248 (0.48%)  7
Transient ischaemic attack * 1  3/244 (1.23%)  3 0/497 (0.00%)  0 3/507 (0.59%)  3 6/751 (0.80%)  6 6/1248 (0.48%)  6
Cerebrovascular accident * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 3/507 (0.59%)  3 4/751 (0.53%)  4 4/1248 (0.32%)  4
Migraine * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 2/507 (0.39%)  2 2/751 (0.27%)  2 4/1248 (0.32%)  4
Syncope * 1  0/244 (0.00%)  0 3/497 (0.60%)  3 1/507 (0.20%)  1 1/751 (0.13%)  1 4/1248 (0.32%)  4
Convulsion * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 1/507 (0.20%)  2 1/751 (0.13%)  2 3/1248 (0.24%)  4
Dizziness * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 1/507 (0.20%)  1 1/751 (0.13%)  1 3/1248 (0.24%)  3
Hypoaesthesia * 1  0/244 (0.00%)  0 3/497 (0.60%)  3 0/507 (0.00%)  0 0/751 (0.00%)  0 3/1248 (0.24%)  3
Dysarthria * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Grand mal convulsion * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Monoparesis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 1/507 (0.20%)  2 1/751 (0.13%)  2 2/1248 (0.16%)  3
Altered state of consciousness * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cerebral haemorrhage * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cerebral infarction * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Cerebrospinal fluid leakage * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cerebrovascular disorder * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Epilepsy * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Haemorrhage intracranial * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Hemiparesis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Ischaemic stroke * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Lumbar radiculopathy * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Lupus encephalitis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Memory impairment * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Motor dysfunction * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Myasthenia gravis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Neuropsychiatric lupus * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Optic neuritis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Polyneuropathy * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Radiculitis brachial * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Radiculopathy * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Seizure anoxic * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Sinus headache * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Thecal sac compression * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Thoracic outlet syndrome * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Transverse sinus thrombosis * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
VIIth nerve paralysis * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous * 1  3/244 (1.23%)  3 0/497 (0.00%)  0 1/507 (0.20%)  1 4/751 (0.53%)  4 4/1248 (0.32%)  4
Foetal death * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Premature delivery * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Psychiatric disorders           
Depression * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 2/507 (0.39%)  2 2/751 (0.27%)  2 4/1248 (0.32%)  4
Suicide attempt * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 2/507 (0.39%)  2 2/751 (0.27%)  2 4/1248 (0.32%)  4
Psychotic disorder * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Suicidal ideation * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Renal and urinary disorders           
Lupus nephritis * 1  2/244 (0.82%)  2 3/497 (0.60%)  3 1/507 (0.20%)  1 3/751 (0.40%)  3 6/1248 (0.48%)  6
Proteinuria * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 2/507 (0.39%)  2 2/751 (0.27%)  2 4/1248 (0.32%)  4
Renal failure acute * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 2/507 (0.39%)  3 2/751 (0.27%)  3 3/1248 (0.24%)  4
Nephrolithiasis * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 0/507 (0.00%)  0 2/751 (0.27%)  2 2/1248 (0.16%)  2
Glomerulonephritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Glomerulonephritis membranoproliferative * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Kidney fibrosis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Nephritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Renal colic * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Stress urinary incontinence * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Reproductive system and breast disorders           
Ovarian cyst * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 2/507 (0.39%)  2 3/751 (0.40%)  3 4/1248 (0.32%)  4
Endometriosis * 1  2/244 (0.82%)  2 1/497 (0.20%)  1 0/507 (0.00%)  0 2/751 (0.27%)  2 3/1248 (0.24%)  3
Cervical dysplasia * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 0/507 (0.00%)  0 2/751 (0.27%)  2 2/1248 (0.16%)  2
Menorrhagia * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Uterine polyp * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 1/507 (0.20%)  1 2/751 (0.27%)  2 2/1248 (0.16%)  2
Adenomyosis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Endometrial hyperplasia * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pelvic pain * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Uterine haemorrhage * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Vaginal prolapse * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  1/244 (0.41%)  1 3/497 (0.60%)  3 1/507 (0.20%)  1 2/751 (0.27%)  2 5/1248 (0.40%)  5
Pulmonary embolism * 1  2/244 (0.82%)  2 0/497 (0.00%)  0 1/507 (0.20%)  1 3/751 (0.40%)  3 3/1248 (0.24%)  3
Cough * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 2/507 (0.39%)  2 2/751 (0.27%)  2 2/1248 (0.16%)  2
Pleurisy * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Acute pulmonary oedema * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Acute respiratory failure * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Asthma * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Chronic obstructive pulmonary disease * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Chronic respiratory failure * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Dyspnoea exertional * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Emphysema * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Laryngeal stenosis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Pleural effusion * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pulmonary arterial hypertension * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Pulmonary hypertension * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Respiratory failure * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Wheezing * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Skin and subcutaneous tissue disorders           
Skin ulcer * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 1/507 (0.20%)  1 2/751 (0.27%)  2 3/1248 (0.24%)  3
Cutaneous vasculitis * 1  1/244 (0.41%)  1 1/497 (0.20%)  1 0/507 (0.00%)  0 1/751 (0.13%)  1 2/1248 (0.16%)  2
Blister * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Chronic cutaneous lupus erythematosus * 1  0/244 (0.00%)  0 1/497 (0.20%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  2
Pruritus generalised * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Systemic lupus erythematosus rash * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Urticaria * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Surgical and medical procedures           
Abortion induced * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Cholecystectomy * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Hip arthroplasty * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Joint arthroplasty * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Polymedication * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Shoulder operation * 1  1/244 (0.41%)  1 0/497 (0.00%)  0 0/507 (0.00%)  0 1/751 (0.13%)  1 1/1248 (0.08%)  1
Vascular disorders           
Deep vein thrombosis * 1  3/244 (1.23%)  3 0/497 (0.00%)  0 2/507 (0.39%)  2 5/751 (0.67%)  5 5/1248 (0.40%)  5
Hypertension * 1  0/244 (0.00%)  0 3/497 (0.60%)  3 0/507 (0.00%)  0 0/751 (0.00%)  0 3/1248 (0.24%)  3
Venous thrombosis * 1  0/244 (0.00%)  0 2/497 (0.40%)  2 0/507 (0.00%)  0 0/751 (0.00%)  0 2/1248 (0.16%)  2
Arterial occlusive disease * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Hypertensive crisis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Orthostatic hypotension * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
Temporal arteritis * 1  0/244 (0.00%)  0 1/497 (0.20%)  1 0/507 (0.00%)  0 0/751 (0.00%)  0 1/1248 (0.08%)  1
Venous thrombosis limb * 1  0/244 (0.00%)  0 0/497 (0.00%)  0 1/507 (0.20%)  1 1/751 (0.13%)  1 1/1248 (0.08%)  1
1
Term from vocabulary, MedDRA17.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enrollment Cohort 1 Epratuzumab 600 mg Per Week Enrollment Cohort 2 Epratuzumab 1200 mg Q2W Enrollment Cohort 2 Epratuzumab 600 mg Per Week All Epratuzumab 600 mg Per Week All Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   177/244 (72.54%)      296/497 (59.56%)      306/507 (60.36%)      483/751 (64.31%)      779/1248 (62.42%)    
Gastrointestinal disorders           
Nausea * 1  39/244 (15.98%)  80 59/497 (11.87%)  86 62/507 (12.23%)  79 101/751 (13.45%)  159 160/1248 (12.82%)  245
Diarrhoea * 1  27/244 (11.07%)  41 47/497 (9.46%)  58 34/507 (6.71%)  47 61/751 (8.12%)  88 108/1248 (8.65%)  146
Vomiting * 1  22/244 (9.02%)  45 32/497 (6.44%)  43 29/507 (5.72%)  38 51/751 (6.79%)  83 83/1248 (6.65%)  126
Fatigue * 1  17/244 (6.97%)  24 19/497 (3.82%)  22 21/507 (4.14%)  22 38/751 (5.06%)  46 57/1248 (4.57%)  68
Infections and infestations           
Upper respiratory tract infection * 1  66/244 (27.05%)  140 76/497 (15.29%)  126 82/507 (16.17%)  120 148/751 (19.71%)  260 224/1248 (17.95%)  386
Urinary tract infection * 1  56/244 (22.95%)  124 61/497 (12.27%)  88 62/507 (12.23%)  90 118/751 (15.71%)  214 179/1248 (14.34%)  302
Nasopharyngitis * 1  38/244 (15.57%)  56 42/497 (8.45%)  65 45/507 (8.88%)  67 83/751 (11.05%)  123 125/1248 (10.02%)  188
Bronchitis * 1  34/244 (13.93%)  38 35/497 (7.04%)  38 35/507 (6.90%)  41 69/751 (9.19%)  79 104/1248 (8.33%)  117
Sinusitis * 1  25/244 (10.25%)  40 41/497 (8.25%)  48 38/507 (7.50%)  48 63/751 (8.39%)  88 104/1248 (8.33%)  136
Influenza * 1  15/244 (6.15%)  16 22/497 (4.43%)  24 21/507 (4.14%)  23 36/751 (4.79%)  39 58/1248 (4.65%)  63
Gastroenteritis * 1  14/244 (5.74%)  14 19/497 (3.82%)  21 17/507 (3.35%)  23 31/751 (4.13%)  37 50/1248 (4.01%)  58
Conjunctivitis * 1  14/244 (5.74%)  16 15/497 (3.02%)  17 8/507 (1.58%)  8 22/751 (2.93%)  24 37/1248 (2.96%)  41
Musculoskeletal and connective tissue disorders           
Back pain * 1  34/244 (13.93%)  47 31/497 (6.24%)  32 32/507 (6.31%)  32 66/751 (8.79%)  79 97/1248 (7.77%)  111
Arthralgia * 1  24/244 (9.84%)  40 36/497 (7.24%)  44 30/507 (5.92%)  38 54/751 (7.19%)  78 90/1248 (7.21%)  122
Systemic lupus erythematosus * 1  15/244 (6.15%)  19 18/497 (3.62%)  26 23/507 (4.54%)  30 38/751 (5.06%)  49 56/1248 (4.49%)  75
Pain in extremity * 1  15/244 (6.15%)  21 15/497 (3.02%)  17 19/507 (3.75%)  21 34/751 (4.53%)  42 49/1248 (3.93%)  59
Muscle spasms * 1  13/244 (5.33%)  14 18/497 (3.62%)  20 6/507 (1.18%)  7 19/751 (2.53%)  21 37/1248 (2.96%)  41
Bursitis * 1  15/244 (6.15%)  24 9/497 (1.81%)  11 7/507 (1.38%)  7 22/751 (2.93%)  31 31/1248 (2.48%)  42
Nervous system disorders           
Headache * 1  46/244 (18.85%)  66 67/497 (13.48%)  84 57/507 (11.24%)  80 103/751 (13.72%)  146 170/1248 (13.62%)  230
Dizziness * 1  20/244 (8.20%)  26 23/497 (4.63%)  30 23/507 (4.54%)  25 43/751 (5.73%)  51 66/1248 (5.29%)  81
Hypoaesthesia * 1  13/244 (5.33%)  15 9/497 (1.81%)  9 12/507 (2.37%)  13 25/751 (3.33%)  28 34/1248 (2.72%)  37
Psychiatric disorders           
Depression * 1  16/244 (6.56%)  17 23/497 (4.63%)  23 15/507 (2.96%)  16 31/751 (4.13%)  33 54/1248 (4.33%)  56
Respiratory, thoracic and mediastinal disorders           
Cough * 1  21/244 (8.61%)  25 30/497 (6.04%)  31 32/507 (6.31%)  43 53/751 (7.06%)  68 83/1248 (6.65%)  99
Oropharyngeal pain * 1  15/244 (6.15%)  24 9/497 (1.81%)  11 14/507 (2.76%)  16 29/751 (3.86%)  40 38/1248 (3.04%)  51
Urticaria * 1  13/244 (5.33%)  20 7/497 (1.41%)  7 4/507 (0.79%)  4 17/751 (2.26%)  24 24/1248 (1.92%)  31
Vascular disorders           
Hypertension * 1  17/244 (6.97%)  19 26/497 (5.23%)  28 26/507 (5.13%)  27 43/751 (5.73%)  46 69/1248 (5.53%)  74
1
Term from vocabulary, MedDRA17.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01408576    
Other Study ID Numbers: SL0012
2010-020859-30 ( EudraCT Number )
First Submitted: August 1, 2011
First Posted: August 3, 2011
Results First Submitted: July 20, 2018
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018