Trial Outcomes & Findings for Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients (NCT NCT00640328)
NCT ID: NCT00640328
Last Updated: 2017-04-11
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section. Non-serious AEs were not collected during the Individualized Follow-up Period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)
Results posted on
2017-04-11
Participant Flow
In all 3 dose cohorts, participants in the active/placebo group received treatment with ofatumumab during the First Treatment Period and placebo during the Second Treatment Period. Participants in the placebo/active group received treatment with placebo during the First Treatment Period and ofatumumab during the second treatment period.
Participant milestones
| Measure |
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
|---|---|---|---|---|---|---|
|
First Treatment Period (Weeks 0-24)
STARTED
|
8
|
11
|
7
|
4
|
4
|
4
|
|
First Treatment Period (Weeks 0-24)
COMPLETED
|
8
|
10
|
7
|
4
|
4
|
4
|
|
First Treatment Period (Weeks 0-24)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Treatment Period (Weeks 24-48)
STARTED
|
8
|
10
|
7
|
4
|
4
|
4
|
|
Second Treatment Period (Weeks 24-48)
COMPLETED
|
8
|
10
|
7
|
4
|
3
|
4
|
|
Second Treatment Period (Weeks 24-48)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
IFUP (Week 48 to Individual Termination)
STARTED
|
8
|
11
|
7
|
4
|
4
|
4
|
|
IFUP (Week 48 to Individual Termination)
COMPLETED
|
8
|
10
|
6
|
3
|
4
|
4
|
|
IFUP (Week 48 to Individual Termination)
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
300 mg Ofa/Matching Placebo
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/100 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/300 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
|---|---|---|---|---|---|---|
|
First Treatment Period (Weeks 0-24)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Second Treatment Period (Weeks 24-48)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
IFUP (Week 48 to Individual Termination)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
IFUP (Week 48 to Individual Termination)
Not Recommended - Informed Consent Form
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients
Baseline characteristics by cohort
| Measure |
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 Years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
36.6 Years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
33.7 Years
STANDARD_DEVIATION 8.4 • n=27 Participants
|
37.0 Years
STANDARD_DEVIATION 6.5 • n=483 Participants
|
27.0 Years
STANDARD_DEVIATION 2.2 • n=36 Participants
|
44.0 Years
STANDARD_DEVIATION 8.1 • n=10 Participants
|
36.3 Years
STANDARD_DEVIATION 7.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 participants
n=93 Participants
|
11 participants
n=4 Participants
|
7 participants
n=27 Participants
|
4 participants
n=483 Participants
|
4 participants
n=36 Participants
|
4 participants
n=10 Participants
|
38 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section. Non-serious AEs were not collected during the Individualized Follow-up Period.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event
Individualized Follow-up Period
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Any Adverse Event
Weeks 0-24
|
2 participants
|
8 participants
|
10 participants
|
7 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Any Adverse Event
Weeks 24-48
|
4 participants
|
4 participants
|
5 participants
|
4 participants
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS
A CAE=treatment-related (TR) grade (G) \>=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Week 24-48; any CAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Individualized Follow-up Period; any CAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Week 0-24; Influenza
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Week 0-24; Bronchospasm
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Week 0-24; Cough
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Critical Adverse Events (CAEs)
Week 0-24; Rash pruritic
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Week 0; n=8, 8, 2, 4, 3, 4
|
4 participants
|
8 participants
|
8 participants
|
2 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Week 24; n=8, 9, 1, 4, 4, 4
|
4 participants
|
8 participants
|
9 participants
|
1 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Week 48 or EW, negative; n=8, 11, 7, 4, 3, 4
|
1 participants
|
8 participants
|
11 participants
|
7 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
Week 48 or EW, unconfirmed, n=8, 11, 7, 4, 3, 4
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)
IFUP, n=8, 11, 7, 4, 4, 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS
The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis \[a brain and spinal cord disease\]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Venous varices on legs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Vertebropathy
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Obesitas
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Increased hearing loss
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Post operative scar
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 0-24; Anhidrotic eczema
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 24-48; Venous varices on legs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 24-48; Vertebropathy
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 24-48; Obesitas
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 24-48; Acne vulgaris
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Week 24-48; Post operative scar
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
IFUP; Any physical examination finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Leukocytes; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
1.30 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Lymphocytes; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-0.60 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Lymphocytes; n=8, 10, 7, 3, 3, 4
|
0.12 Giga (10^9) per liter
Standard Deviation 0.21
|
0.15 Giga (10^9) per liter
Standard Deviation 1.03
|
-0.36 Giga (10^9) per liter
Standard Deviation 0.67
|
-0.19 Giga (10^9) per liter
Standard Deviation 0.78
|
-0.37 Giga (10^9) per liter
Standard Deviation 0.31
|
-0.60 Giga (10^9) per liter
Standard Deviation 0.79
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Monocytes; n=8, 10, 7, 3, 3, 4
|
0.05 Giga (10^9) per liter
Standard Deviation 0.10
|
0.20 Giga (10^9) per liter
Standard Deviation 0.31
|
-0.07 Giga (10^9) per liter
Standard Deviation 0.23
|
0.00 Giga (10^9) per liter
Standard Deviation 0.20
|
0.07 Giga (10^9) per liter
Standard Deviation 0.06
|
-0.40 Giga (10^9) per liter
Standard Deviation 0.17
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Basophils; n=7, 10, 7, 3, 3, 4
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Eosinophils; n=8, 10, 6, 2, 3, 4
|
0.03 Giga (10^9) per liter
Standard Deviation 0.05
|
0 Giga (10^9) per liter
Standard Deviation 0.05
|
-0.05 Giga (10^9) per liter
Standard Deviation 0.13
|
0.02 Giga (10^9) per liter
Standard Deviation 0.15
|
0 Giga (10^9) per liter
Standard Deviation 0
|
-0.23 Giga (10^9) per liter
Standard Deviation 0.21
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Leukocytes; n=8, 10, 7, 3, 4, 4
|
0.4 Giga (10^9) per liter
Standard Deviation 0.7
|
0.7 Giga (10^9) per liter
Standard Deviation 1.6
|
0.6 Giga (10^9) per liter
Standard Deviation 2.4
|
-0.1 Giga (10^9) per liter
Standard Deviation 3.3
|
-0.3 Giga (10^9) per liter
Standard Deviation 1.6
|
0.7 Giga (10^9) per liter
Standard Deviation 5.9
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Eosinophils; n=8, 8, 5, 3, 2, 4
|
0.03 Giga (10^9) per liter
Standard Deviation 0.13
|
0 Giga (10^9) per liter
Standard Deviation 0.05
|
-0.04 Giga (10^9) per liter
Standard Deviation 0.16
|
0.04 Giga (10^9) per liter
Standard Deviation 0.09
|
-0.07 Giga (10^9) per liter
Standard Deviation 0.06
|
-0.20 Giga (10^9) per liter
Standard Deviation 0.28
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Neutrophils; n=8, 10, 7, 3, 3, 4
|
0.2 Giga (10^9) per liter
Standard Deviation 0.7
|
0.4 Giga (10^9) per liter
Standard Deviation 0.9
|
1 Giga (10^9) per liter
Standard Deviation 2.2
|
0 Giga (10^9) per liter
Standard Deviation 3.8
|
-0.1 Giga (10^9) per liter
Standard Deviation 1.5
|
-0.8 Giga (10^9) per liter
Standard Deviation 1.7
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-24, Platelets; n=8, 10, 7, 3, 4, 4
|
-4.8 Giga (10^9) per liter
Standard Deviation 34.8
|
0.8 Giga (10^9) per liter
Standard Deviation 33.3
|
10.8 Giga (10^9) per liter
Standard Deviation 44.0
|
7.6 Giga (10^9) per liter
Standard Deviation 39.7
|
0.3 Giga (10^9) per liter
Standard Deviation 29.5
|
5.8 Giga (10^9) per liter
Standard Deviation 36.2
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Basophils; n=8, 8, 5, 3, 2, 3
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
0 Giga (10^9) per liter
Standard Deviation 0
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Leukocytes; n=8, 10, 7, 3, 3, 4
|
0.9 Giga (10^9) per liter
Standard Deviation 0.9
|
0.5 Giga (10^9) per liter
Standard Deviation 1.1
|
-0.1 Giga (10^9) per liter
Standard Deviation 1.7
|
-0.3 Giga (10^9) per liter
Standard Deviation 1.1
|
-0.9 Giga (10^9) per liter
Standard Deviation 0.6
|
-3.7 Giga (10^9) per liter
Standard Deviation 1.7
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Lymphocytes; n=8, 8, 6, 3, 2, 4
|
-0.25 Giga (10^9) per liter
Standard Deviation 0.45
|
-0.11 Giga (10^9) per liter
Standard Deviation 0.36
|
-0.28 Giga (10^9) per liter
Standard Deviation 0.47
|
0.15 Giga (10^9) per liter
Standard Deviation 0.36
|
-0.50 Giga (10^9) per liter
Standard Deviation 0.20
|
-0.65 Giga (10^9) per liter
Standard Deviation 0.78
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Monocytes; n=8, 8, 6, 3, 2, 4
|
0.13 Giga (10^9) per liter
Standard Deviation 0.25
|
-0.20 Giga (10^9) per liter
Standard Deviation 0.07
|
-0.01 Giga (10^9) per liter
Standard Deviation 0.12
|
0.02 Giga (10^9) per liter
Standard Deviation 0.17
|
0.03 Giga (10^9) per liter
Standard Deviation 0.06
|
-0.04 Giga (10^9) per liter
Standard Deviation 0.28
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Neutrophils; n=8, 8, 6, 3, 2, 4
|
1.0 Giga (10^9) per liter
Standard Deviation 0.7
|
0.7 Giga (10^9) per liter
Standard Deviation 1.2
|
0.2 Giga (10^9) per liter
Standard Deviation 1.8
|
-0.4 Giga (10^9) per liter
Standard Deviation 1.0
|
-0.4 Giga (10^9) per liter
Standard Deviation 0.4
|
-2.9 Giga (10^9) per liter
Standard Deviation 1.3
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24-48, Platelets; n=8, 10, 7, 3, 3, 4
|
-11.0 Giga (10^9) per liter
Standard Deviation 38.4
|
-6.5 Giga (10^9) per liter
Standard Deviation 17.3
|
-16.3 Giga (10^9) per liter
Standard Deviation 74.2
|
-10.1 Giga (10^9) per liter
Standard Deviation 14.7
|
-13.7 Giga (10^9) per liter
Standard Deviation 20.6
|
-34.3 Giga (10^9) per liter
Standard Deviation 47.3
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Basophils; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Eosinophils; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Monocytes; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Neutrophils; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
1.90 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 0-104, Platelets; n=1, 0, 0, 0, 0, 0
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-20.0 Giga (10^9) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Giga (10^9) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104; n=1, 0, 0, 0, 0, 0
|
NA Pico (10^12) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-0.08 Pico (10^12) per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Pico (10^12) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Pico (10^12) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Pico (10^12) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Pico (10^12) per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24; n=8, 10, 7, 3, 4, 4
|
0.07 Pico (10^12) per liter
Standard Deviation 0.12
|
0.06 Pico (10^12) per liter
Standard Deviation 0.25
|
-0.11 Pico (10^12) per liter
Standard Deviation 0.33
|
-0.02 Pico (10^12) per liter
Standard Deviation 0.23
|
-0.09 Pico (10^12) per liter
Standard Deviation 0.20
|
-0.06 Pico (10^12) per liter
Standard Deviation 0.42
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48; n=8, 10, 7, 3, 3, 4
|
0.09 Pico (10^12) per liter
Standard Deviation 0.04
|
0.05 Pico (10^12) per liter
Standard Deviation 0.26
|
0.12 Pico (10^12) per liter
Standard Deviation 0.34
|
0.12 Pico (10^12) per liter
Standard Deviation 0.25
|
0.01 Pico (10^12) per liter
Standard Deviation 0.43
|
0.06 Pico (10^12) per liter
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24; n=8, 10, 7, 3, 4, 4
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.01
|
-0.00 Percentage of BV occupied by RBCs
Standard Deviation 0.03
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.03
|
-0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.02
|
-0.02 Percentage of BV occupied by RBCs
Standard Deviation 0.02
|
0.02 Percentage of BV occupied by RBCs
Standard Deviation 0.04
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48; n=8, 10, 7, 3, 3, 4
|
0.02 Percentage of BV occupied by RBCs
Standard Deviation 0.01
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.02
|
0.02 Percentage of BV occupied by RBCs
Standard Deviation 0.03
|
0.00 Percentage of BV occupied by RBCs
Standard Deviation 0.03
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.05
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation 0.01
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104; n=1, 0, 0, 0, 0, 0
|
NA Percentage of BV occupied by RBCs
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.01 Percentage of BV occupied by RBCs
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Percentage of BV occupied by RBCs
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Percentage of BV occupied by RBCs
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Percentage of BV occupied by RBCs
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Percentage of BV occupied by RBCs
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24; n=8, 10, 7, 3, 4, 4
|
0.2 Millimoles/liter
Standard Deviation 0.2
|
0.1 Millimoles/liter
Standard Deviation 0.5
|
-0.3 Millimoles/liter
Standard Deviation 0.7
|
-0.0 Millimoles/liter
Standard Deviation 0.5
|
-0.4 Millimoles/liter
Standard Deviation 0.4
|
-0.1 Millimoles/liter
Standard Deviation 0.8
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48; n=8, 10, 7, 3, 3, 4
|
0.5 Millimoles/liter
Standard Deviation 0.3
|
0.1 Millimoles/liter
Standard Deviation 0.5
|
0.1 Millimoles/liter
Standard Deviation 0.7
|
0.2 Millimoles/liter
Standard Deviation 0.5
|
-0.3 Millimoles/liter
Standard Deviation 1.1
|
0.0 Millimoles/liter
Standard Deviation 0.3
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104; n=1, 0, 0, 0, 0, 0
|
NA Millimoles/liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.10 Millimoles/liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Millimoles/liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Millimoles/liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Millimoles/liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Millimoles/liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24; n=8, 10, 6, 4, 4, 4
|
2.0 grams per liter
Standard Deviation 2.4
|
-0.6 grams per liter
Standard Deviation 2.5
|
-0.5 grams per liter
Standard Deviation 2.5
|
1.3 grams per liter
Standard Deviation 1.2
|
-1.6 grams per liter
Standard Deviation 3.4
|
-1.2 grams per liter
Standard Deviation 6.1
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48; n=8, 11, 7, 4, 3, 4
|
1.1 grams per liter
Standard Deviation 1.5
|
0.1 grams per liter
Standard Deviation 2.5
|
-0.2 grams per liter
Standard Deviation 3.1
|
1.4 grams per liter
Standard Deviation 3.0
|
-1.1 grams per liter
Standard Deviation 5.7
|
0.4 grams per liter
Standard Deviation 4.0
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104; n=1, 0, 0, 0, 0, 0
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-2.00 grams per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Alkaline phosphatase; n=8, 11, 7, 4, 3, 4
|
12.5 Units per liter
Standard Deviation 12.9
|
7.6 Units per liter
Standard Deviation 10.7
|
3.1 Units per liter
Standard Deviation 8.8
|
9.1 Units per liter
Standard Deviation 12.6
|
5.3 Units per liter
Standard Deviation 17.7
|
5.7 Units per liter
Standard Deviation 7.6
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, ALT; n=8, 10, 6, 4, 4, 4
|
0 Units per liter
Standard Deviation 13.0
|
7.1 Units per liter
Standard Deviation 10.2
|
4.7 Units per liter
Standard Deviation 10.0
|
-1.7 Units per liter
Standard Deviation 6.4
|
7.3 Units per liter
Standard Deviation 24.4
|
5.3 Units per liter
Standard Deviation 5.4
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Alkaline phosphatase; n=8, 10, 6, 4, 4, 4
|
8.8 Units per liter
Standard Deviation 8.3
|
4.8 Units per liter
Standard Deviation 9.0
|
3.8 Units per liter
Standard Deviation 11.9
|
2.7 Units per liter
Standard Deviation 8.3
|
13.0 Units per liter
Standard Deviation 20.2
|
2.3 Units per liter
Standard Deviation 10.6
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, AST; n=8, 10, 6, 4, 4, 4
|
-1.0 Units per liter
Standard Deviation 6.1
|
3.6 Units per liter
Standard Deviation 5.1
|
1.6 Units per liter
Standard Deviation 6.3
|
-0.2 Units per liter
Standard Deviation 3.1
|
-9.5 Units per liter
Standard Deviation 28.6
|
4.3 Units per liter
Standard Deviation 3.2
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, AST; n=8, 11, 7, 4, 3, 4
|
3.3 Units per liter
Standard Deviation 10.7
|
0.6 Units per liter
Standard Deviation 2.6
|
1.5 Units per liter
Standard Deviation 3.0
|
0.3 Units per liter
Standard Deviation 2.5
|
-13.3 Units per liter
Standard Deviation 28.5
|
0.7 Units per liter
Standard Deviation 4.7
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, ALT; n=8, 11, 7, 4, 3, 4
|
8.0 Units per liter
Standard Deviation 20.4
|
2.8 Units per liter
Standard Deviation 5.3
|
0.6 Units per liter
Standard Deviation 4.7
|
0.6 Units per liter
Standard Deviation 7.4
|
-4.3 Units per liter
Standard Deviation 9.3
|
0.7 Units per liter
Standard Deviation 8.1
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Alkaline phosphatase; n=1,0,0,0,0,0
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
16.0 Units per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, AST; n=1, 0, 0, 0, 0, 0
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
2.0 Units per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, ALT; n=1, 0, 0, 0, 0, 0
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
2.0 Units per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Units per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Urea; n=8, 11, 7, 4, 3, 4
|
-0.17 millimoles per liter
Standard Deviation 0.46
|
0.13 millimoles per liter
Standard Deviation 1.40
|
-0.05 millimoles per liter
Standard Deviation 1.32
|
-0.19 millimoles per liter
Standard Deviation 0.68
|
-0.30 millimoles per liter
Standard Deviation 1.04
|
1.00 millimoles per liter
Standard Deviation 2.20
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Bicarbonate; n=8, 10, 6, 4, 4, 4
|
-0.6 millimoles per liter
Standard Deviation 4.0
|
0.6 millimoles per liter
Standard Deviation 2.2
|
-1.1 millimoles per liter
Standard Deviation 2.6
|
-0.6 millimoles per liter
Standard Deviation 2.5
|
1.5 millimoles per liter
Standard Deviation 3.2
|
-2.0 millimoles per liter
Standard Deviation 1.3
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Glucose; n=8, 10, 7, 4, 4, 4
|
-0.22 millimoles per liter
Standard Deviation 0.50
|
-0.12 millimoles per liter
Standard Deviation 0.59
|
0.39 millimoles per liter
Standard Deviation 1.37
|
0.64 millimoles per liter
Standard Deviation 1.23
|
0.21 millimoles per liter
Standard Deviation 0.42
|
0.08 millimoles per liter
Standard Deviation 0.63
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Potassium; n=8, 10, 6, 4, 4, 4
|
-0.00 millimoles per liter
Standard Deviation 0.16
|
-0.07 millimoles per liter
Standard Deviation 0.35
|
0.06 millimoles per liter
Standard Deviation 0.52
|
0.03 millimoles per liter
Standard Deviation 0.27
|
-0.63 millimoles per liter
Standard Deviation 1.01
|
-0.20 millimoles per liter
Standard Deviation 0.63
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Sodium; n=8, 10, 6, 4, 4, 4
|
0.5 millimoles per liter
Standard Deviation 2.1
|
0.4 millimoles per liter
Standard Deviation 2.7
|
-0.5 millimoles per liter
Standard Deviation 2.8
|
-1.2 millimoles per liter
Standard Deviation 1.3
|
0.5 millimoles per liter
Standard Deviation 1.7
|
0.8 millimoles per liter
Standard Deviation 2.1
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Urea; n=8, 10, 6, 4, 4, 4
|
-0.1 millimoles per liter
Standard Deviation 0.4
|
0.5 millimoles per liter
Standard Deviation 1.6
|
-0.8 millimoles per liter
Standard Deviation 1.6
|
0.4 millimoles per liter
Standard Deviation 1.5
|
-0.6 millimoles per liter
Standard Deviation 0.8
|
-0.7 millimoles per liter
Standard Deviation 2.1
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Bicarbonate; n=8, 11, 7, 4, 4, 4
|
1.0 millimoles per liter
Standard Deviation 2.3
|
-0.0 millimoles per liter
Standard Deviation 2.9
|
-0.7 millimoles per liter
Standard Deviation 2.8
|
0.6 millimoles per liter
Standard Deviation 1.3
|
0.6 millimoles per liter
Standard Deviation 0.2
|
1.9 millimoles per liter
Standard Deviation 3.1
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Glucose; n=8, 10, 7, 4, 2, 4
|
0.27 millimoles per liter
Standard Deviation 0.79
|
0.10 millimoles per liter
Standard Deviation 0.50
|
0.25 millimoles per liter
Standard Deviation 0.95
|
-0.05 millimoles per liter
Standard Deviation 0.51
|
0.09 millimoles per liter
Standard Deviation 0.56
|
-0.64 millimoles per liter
Standard Deviation 0.44
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Potassium; n=8, 10, 6, 4, 4, 4
|
4.20 millimoles per liter
Standard Deviation 0.32
|
4.21 millimoles per liter
Standard Deviation 0.11
|
4.43 millimoles per liter
Standard Deviation 0.44
|
4.18 millimoles per liter
Standard Deviation 0.34
|
4.23 millimoles per liter
Standard Deviation 0.32
|
3.98 millimoles per liter
Standard Deviation 0.10
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Sodium; n=8, 11, 7, 4, 3, 4
|
0.8 millimoles per liter
Standard Deviation 1.0
|
-2.3 millimoles per liter
Standard Deviation 1.6
|
-0.07 millimoles per liter
Standard Deviation 3.1
|
0.7 millimoles per liter
Standard Deviation 1.0
|
-0.5 millimoles per liter
Standard Deviation 3.7
|
-0.7 millimoles per liter
Standard Deviation 1.2
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Bicarbonate; n=1, 0, 0, 0, 0, 0
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-1.00 millimoles per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Glucose; n=1, 0, 0, 0, 0, 0
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
1.77 millimoles per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Potassium; n=1, 0, 0, 0, 0, 0
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.00 millimoles per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Sodium; n=1, 0, 0, 0, 0, 0
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
1.00 millimoles per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Urea; n=1, 0, 0, 0, 0, 0
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
1.00 millimoles per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA millimoles per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Bilirubin; n=8, 10, 5, 4, 4, 4
|
0.3 Micromoles per liter (µmol/L)
Standard Deviation 5.3
|
0.7 Micromoles per liter (µmol/L)
Standard Deviation 5.2
|
-0.0 Micromoles per liter (µmol/L)
Standard Deviation 4.0
|
1.2 Micromoles per liter (µmol/L)
Standard Deviation 2.2
|
0.5 Micromoles per liter (µmol/L)
Standard Deviation 4.0
|
-2.6 Micromoles per liter (µmol/L)
Standard Deviation 3.5
|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, Creatinine; n=8, 10, 6, 4, 4, 4
|
-1.2 Micromoles per liter (µmol/L)
Standard Deviation 4.0
|
3.2 Micromoles per liter (µmol/L)
Standard Deviation 11.8
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 7.6
|
2.5 Micromoles per liter (µmol/L)
Standard Deviation 4.7
|
2.5 Micromoles per liter (µmol/L)
Standard Deviation 5.7
|
-2.9 Micromoles per liter (µmol/L)
Standard Deviation 7.8
|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Bilirubin; n=8, 10, 6, 4, 2, 4
|
0.6 Micromoles per liter (µmol/L)
Standard Deviation 2.8
|
1.5 Micromoles per liter (µmol/L)
Standard Deviation 4.9
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 4.8
|
1.5 Micromoles per liter (µmol/L)
Standard Deviation 3.5
|
0.7 Micromoles per liter (µmol/L)
Standard Deviation 3.4
|
-2.8 Micromoles per liter (µmol/L)
Standard Deviation 1.0
|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, Creatinine; n=8, 11, 7, 4, 3, 4
|
2.0 Micromoles per liter (µmol/L)
Standard Deviation 12.5
|
3.0 Micromoles per liter (µmol/L)
Standard Deviation 8.7
|
-1.9 Micromoles per liter (µmol/L)
Standard Deviation 5.3
|
-0.3 Micromoles per liter (µmol/L)
Standard Deviation 4.1
|
3.5 Micromoles per liter (µmol/L)
Standard Deviation 6.7
|
-5.0 Micromoles per liter (µmol/L)
Standard Deviation 6.5
|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Bilirubin; n=1, 0, 0, 0, 0, 0
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-4.70 Micromoles per liter (µmol/L)
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, Creatinine; n=1, 0, 0, 0, 0, 0
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
11.5 Micromoles per liter (µmol/L)
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA Micromoles per liter (µmol/L)
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, IGA; n=8, 10, 6, 4, 4, 4
|
0.49 grams per liter
Standard Deviation 0.35
|
0.05 grams per liter
Standard Deviation 0.16
|
0.08 grams per liter
Standard Deviation 0.16
|
0.40 grams per liter
Standard Deviation 0.40
|
-0.07 grams per liter
Standard Deviation 0.18
|
0 grams per liter
Standard Deviation 0.44
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, IGG; n=8, 10, 6, 4, 4, 4
|
1.4 grams per liter
Standard Deviation 0.9
|
-0.6 grams per liter
Standard Deviation 1.0
|
-0.1 grams per liter
Standard Deviation 0.8
|
1.2 grams per liter
Standard Deviation 1.0
|
-0.5 grams per liter
Standard Deviation 1.0
|
-0.3 grams per liter
Standard Deviation 0.9
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 24, IGM; n=8, 10, 6, 4, 4, 4
|
0.04 grams per liter
Standard Deviation 0.08
|
-0.09 grams per liter
Standard Deviation 0.14
|
-0.13 grams per liter
Standard Deviation 0.39
|
-0.19 grams per liter
Standard Deviation 0.09
|
0.25 grams per liter
Standard Deviation 0.25
|
-0.07 grams per liter
Standard Deviation 0.19
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, IGA; n=8, 11, 7, 4, 3, 4
|
0.29 grams per liter
Standard Deviation 0.26
|
0.08 grams per liter
Standard Deviation 0.24
|
-0.03 grams per liter
Standard Deviation 0.39
|
0.13 grams per liter
Standard Deviation 0.11
|
-0.00 grams per liter
Standard Deviation 0.24
|
0.05 grams per liter
Standard Deviation 0.21
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, IGG; n=8, 11, 7, 4, 3, 4
|
1.2 grams per liter
Standard Deviation 0.6
|
-0.8 grams per liter
Standard Deviation 1.2
|
0.5 grams per liter
Standard Deviation 1.6
|
1.0 grams per liter
Standard Deviation 0.7
|
-0.6 grams per liter
Standard Deviation 1.2
|
0.2 grams per liter
Standard Deviation 1.6
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 48, IGM; n=8, 11, 7, 4, 3, 4
|
-0.13 grams per liter
Standard Deviation 0.04
|
-0.17 grams per liter
Standard Deviation 0.24
|
-0.21 grams per liter
Standard Deviation 0.22
|
-0.18 grams per liter
Standard Deviation 0.24
|
-0.24 grams per liter
Standard Deviation 0.24
|
-0.40 grams per liter
Standard Deviation 0.17
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, IGA; n=1, 0, 0, 0, 0, 0
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-0.23 grams per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, IGG; n=1, 0, 0, 0, 0, 0
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-0.60 grams per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)
Week 104, IGM; n=1, 0, 0, 0, 0, 0
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
-0.07 grams per liter
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA grams per liter
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Week 24, Diastolic BP; n=8, 10, 7, 4, 4, 4
|
-1.8 millimeters of mercury
Standard Deviation 2.2
|
5.3 millimeters of mercury
Standard Deviation 11.2
|
-2.3 millimeters of mercury
Standard Deviation 11.1
|
-5.4 millimeters of mercury
Standard Deviation 9.7
|
-3.5 millimeters of mercury
Standard Deviation 7.2
|
4.0 millimeters of mercury
Standard Deviation 4.9
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Week 24, Systolic BP; n=8, 10, 7, 4, 4, 4
|
-6.5 millimeters of mercury
Standard Deviation 9.5
|
11.0 millimeters of mercury
Standard Deviation 19.7
|
-2.5 millimeters of mercury
Standard Deviation 12.3
|
-3.1 millimeters of mercury
Standard Deviation 14.2
|
1.5 millimeters of mercury
Standard Deviation 11.3
|
1.0 millimeters of mercury
Standard Deviation 9.0
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Week 48, Diastolic BP; n=8, 11, 7, 4, 3, 4
|
6.0 millimeters of mercury
Standard Deviation 5.8
|
6.6 millimeters of mercury
Standard Deviation 4.6
|
2.1 millimeters of mercury
Standard Deviation 12.0
|
0.1 millimeters of mercury
Standard Deviation 7.8
|
3.0 millimeters of mercury
Standard Deviation 4.7
|
3.3 millimeters of mercury
Standard Deviation 5.8
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)
Week 48, Systolic BP; n=8, 11, 7, 4, 3, 4
|
4.5 millimeters of mercury
Standard Deviation 1.0
|
2.0 millimeters of mercury
Standard Deviation 14.5
|
-2.5 millimeters of mercury
Standard Deviation 13.9
|
-4.9 millimeters of mercury
Standard Deviation 8.2
|
-2.3 millimeters of mercury
Standard Deviation 7.4
|
1.7 millimeters of mercury
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
Week 24; n=8, 10, 7, 4, 4, 4
|
3.8 beats per minute
Standard Deviation 8.1
|
-0.3 beats per minute
Standard Deviation 11.5
|
1.6 beats per minute
Standard Deviation 8.4
|
0.6 beats per minute
Standard Deviation 10.7
|
1.3 beats per minute
Standard Deviation 13.8
|
2.0 beats per minute
Standard Deviation 8.0
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)
Week 48; n=8, 11, 7, 4, 3, 4
|
8.0 beats per minute
Standard Deviation 5.0
|
-0.1 beats per minute
Standard Deviation 9.8
|
0.4 beats per minute
Standard Deviation 11.9
|
-3.0 beats per minute
Standard Deviation 10.7
|
-5.5 beats per minute
Standard Deviation 10.0
|
-0.3 beats per minute
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
Week 24; n=8, 10, 7, 4, 4, 4
|
-0.3 Degrees Celsius
Standard Deviation 0.3
|
-0.1 Degrees Celsius
Standard Deviation 0.5
|
0.1 Degrees Celsius
Standard Deviation 0.2
|
-0.2 Degrees Celsius
Standard Deviation 0.5
|
-0.1 Degrees Celsius
Standard Deviation 0.4
|
0.3 Degrees Celsius
Standard Deviation 0.5
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)
Week 48; n=8, 11, 7, 4, 3, 4
|
0.1 Degrees Celsius
Standard Deviation 0.3
|
-0.1 Degrees Celsius
Standard Deviation 0.4
|
0.1 Degrees Celsius
Standard Deviation 0.2
|
0.1 Degrees Celsius
Standard Deviation 0.5
|
-0.1 Degrees Celsius
Standard Deviation 0.2
|
0.2 Degrees Celsius
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=2 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
Week 24; n=8, 7, 0, 4, 2, 0
|
—
|
-0.6 Units per milliliter
Standard Deviation 4.1
|
-7.1 Units per milliliter
Standard Deviation 12.9
|
—
|
2.8 Units per milliliter
Standard Deviation 9.1
|
-19.5 Units per milliliter
Standard Deviation 24.7
|
|
Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)
Week 48; n=4, 0, 0, 1, 0, 0
|
—
|
3.8 Units per milliliter
Standard Deviation 7.8
|
NA Units per milliliter
Standard Deviation NA
Data were not collected for this cohort.
|
—
|
-31.0 Units per milliliter
Standard Deviation 0
|
NA Units per milliliter
Standard Deviation NA
Data were not collected for this cohort.
|
SECONDARY outcome
Timeframe: FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. "Total T1 enhancing Ls" represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 24, New (N) T1 enhancing Ls; n=8,11,7,4,4, 4
|
2.50 lesions
Standard Deviation 3.32
|
0.13 lesions
Standard Deviation 0.35
|
0 lesions
Standard Deviation 0
|
0 lesions
Standard Deviation 0
|
3.06 lesions
Standard Deviation 4.66
|
23.50 lesions
Standard Deviation 43.0
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 24, Total T1 enhancing Ls; n=8,11,7,4,4,4
|
4.50 lesions
Standard Deviation 7.14
|
0.13 lesions
Standard Deviation 0.35
|
0.09 lesions
Standard Deviation 0.30
|
0 lesions
Standard Deviation 0
|
3.63 lesions
Standard Deviation 5.02
|
25.75 lesions
Standard Deviation 46.23
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 24, N and/or enlarging T2 Ls; n=8,11,7,4,4,4
|
3.00 lesions
Standard Deviation 4.24
|
0.25 lesions
Standard Deviation 0.71
|
0.09 lesions
Standard Deviation 0.30
|
0 lesions
Standard Deviation 0
|
4.00 lesions
Standard Deviation 6.52
|
25.00 lesions
Standard Deviation 46.03
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 24, N T1 hypointense Ls; n=8,11,7,4, 4,4
|
0.25 lesions
Standard Deviation 0.50
|
0 lesions
Standard Deviation 0
|
0.27 lesions
Standard Deviation 0.47
|
0.29 lesions
Standard Deviation 0.49
|
1.50 lesions
Standard Deviation 3.00
|
5.00 lesions
Standard Deviation 9.35
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 48, N T1 enhancing Ls; n=8,10,7,4,3,4
|
0 lesions
Standard Deviation 0
|
0.13 lesions
Standard Deviation 0.35
|
0 lesions
Standard Deviation 0
|
0.29 lesions
Standard Deviation 0.76
|
0 lesions
Standard Deviation 0
|
0.33 lesions
Standard Deviation 0.58
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 48, Total T1 enhancing Ls; n=8,10,7,4,3,4
|
0 lesions
Standard Deviation 0
|
0.13 lesions
Standard Deviation 0.35
|
0 lesions
Standard Deviation 0
|
0.43 lesions
Standard Deviation 1.13
|
0 lesions
Standard Deviation 0
|
3.00 lesions
Standard Deviation 5.20
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 48, N and/or enlarging T2 Ls; n=8,10,7,4, 3,4
|
0 lesions
Standard Deviation 0
|
0.13 lesions
Standard Deviation 0.35
|
0 lesions
Standard Deviation 0
|
0.29 lesions
Standard Deviation 0.76
|
0 lesions
Standard Deviation 0
|
0.33 lesions
Standard Deviation 0.58
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 48, N T1 hypointense Ls; n=8,10,7,4,3,4
|
0 lesions
Standard Deviation 0
|
0 lesions
Standard Deviation 0
|
0 lesions
Standard Deviation 0
|
0 lesions
Standard Deviation 0
|
0 lesions
Standard Deviation 0
|
3.00 lesions
Standard Deviation 4.36
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 104, N T1 enhancing Ls; n=1, 0, 0, 0, 0, 0
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.0 lesions
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 104, Total T1 enhancing Ls; n=1, 0, 0, 0, 0,0
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.0 lesions
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 104, N and /or enlarging T2 Ls; n=1,0,0,0,0,0
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.0 lesions
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
|
Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)
Week 104, N T1 hypointense Ls; n=1, 0, 0, 0, 0, 0
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
0.0 lesions
Standard Deviation NA
Only one participant in this treatment arm was assessed for this parameter at this time point; thus, the standard deviation cannot be calculated.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
NA lesions
Standard Deviation NA
No participants were analyzed in this treatment arm at this time point.
|
SECONDARY outcome
Timeframe: Visit 10 (Week 24) and Visit 17 (Week 48)Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=11 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=7 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Total Volume of T2 Lesions at Week 24 and Week 48
Week 24; n=8, 11, 7, 3, 4, 4
|
15039 millimeters cubed
Standard Deviation 8984
|
7898 millimeters cubed
Standard Deviation 8802
|
10323 millimeters cubed
Standard Deviation 8281
|
17399 millimeters cubed
Standard Deviation 11641
|
11290 millimeters cubed
Standard Deviation 11746
|
12194 millimeters cubed
Standard Deviation 18008
|
|
Total Volume of T2 Lesions at Week 24 and Week 48
Week 48; n=8, 10, 7, 4, 3, 4
|
15166 millimeters cubed
Standard Deviation 9060
|
7791 millimeters cubed
Standard Deviation 8878
|
11304 millimeters cubed
Standard Deviation 8269
|
17566 millimeters cubed
Standard Deviation 12413
|
10684 millimeters cubed
Standard Deviation 8903
|
18164 millimeters cubed
Standard Deviation 23696
|
SECONDARY outcome
Timeframe: Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Week 0; n=8, 10, 6, 0, 0, 0
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
32.3 milligrams per liter
Standard Deviation 9.65
|
85.8 milligrams per liter
Standard Deviation 53.7
|
176 milligrams per liter
Standard Deviation 24.2
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Week 2; n=8, 10, 6, 0, 0, 0
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
23.4 milligrams per liter
Standard Deviation 19.9
|
64.9 milligrams per liter
Standard Deviation 67.1
|
174 milligrams per liter
Standard Deviation 187
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Week 24; n=0, 0, 0, 4, 3, 4
|
72.7 milligrams per liter
Standard Deviation 128
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
28.9 milligrams per liter
Standard Deviation 8.03
|
43.4 milligrams per liter
Standard Deviation 67.9
|
|
Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions
Week 26; n=0, 0, 0, 4, 3, 4
|
82.4 milligrams per liter
Standard Deviation 144
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Standard Deviation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
21.6 milligrams per liter
Standard Deviation 18.5
|
47.7 milligrams per liter
Standard Deviation 76.9
|
SECONDARY outcome
Timeframe: Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 0; n=8, 10, 6, 0, 0, 0
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
36.8 milligrams per liter
Geometric Coefficient of Variation 13.1
|
124 milligrams per liter
Geometric Coefficient of Variation 23.6
|
346 milligrams per liter
Geometric Coefficient of Variation 24.0
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 2; n=8, 10, 6, 0, 0, 0
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
47.7 milligrams per liter
Geometric Coefficient of Variation 14.7
|
157 milligrams per liter
Geometric Coefficient of Variation 25.9
|
452 milligrams per liter
Geometric Coefficient of Variation 28.5
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 24; n=0, 0, 0, 4, 3, 4
|
312 milligrams per liter
Geometric Coefficient of Variation 24.5
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
33.2 milligrams per liter
Geometric Coefficient of Variation 13.7
|
137 milligrams per liter
Geometric Coefficient of Variation 40.7
|
|
The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 26; n=0, 0, 0, 4, 3, 4
|
416 milligrams per liter
Geometric Coefficient of Variation 24.6
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA milligrams per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
43.5 milligrams per liter
Geometric Coefficient of Variation 25.2
|
210 milligrams per liter
Geometric Coefficient of Variation 54.1
|
SECONDARY outcome
Timeframe: Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 0; n=8, 10, 6, 0, 0, 0
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
153 Millgram hour per liter
Geometric Coefficient of Variation 19.4
|
498 Millgram hour per liter
Geometric Coefficient of Variation 18.6
|
1528 Millgram hour per liter
Geometric Coefficient of Variation 20.7
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 2; n=8, 10, 6, 0, 0, 0
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
15559 Millgram hour per liter
Geometric Coefficient of Variation 34.4
|
63165 Millgram hour per liter
Geometric Coefficient of Variation 40.6
|
225876 Millgram hour per liter
Geometric Coefficient of Variation 30.4
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 24; n=0, 0, 0, 4, 3, 4
|
1347 Millgram hour per liter
Geometric Coefficient of Variation 29.1
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
123 Millgram hour per liter
Geometric Coefficient of Variation 8.6
|
624 Millgram hour per liter
Geometric Coefficient of Variation 32.7
|
|
The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 26; n=0, 0, 0, 4, 3, 4
|
217757 Millgram hour per liter
Geometric Coefficient of Variation 44.5
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA Millgram hour per liter
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
12763 Millgram hour per liter
Geometric Coefficient of Variation 29.3
|
71041 Millgram hour per liter
Geometric Coefficient of Variation 54.9
|
SECONDARY outcome
Timeframe: Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for tmax.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 2; n=8, 10, 6, 0, 0, 0
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
4.25 hours
Interval 3.42 to 5.58
|
4.33 hours
Interval 3.52 to 6.13
|
3.83 hours
Interval 3.67 to 4.5
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 0; n=8, 10, 6, 0, 0, 0
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
5.33 hours
Interval 4.0 to 8.6
|
5.88 hours
Interval 4.17 to 7.67
|
6.00 hours
Interval 5.17 to 9.42
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA hours
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 24; n=0, 0, 0, 4, 3, 4
|
6.54 hours
Interval 4.13 to 8.17
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
4.42 hours
Interval 4.08 to 6.0
|
6.00 hours
Interval 4.17 to 6.92
|
|
Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions
Week 26; n=0, 0, 0, 4, 3, 4
|
4.50 hours
Interval 3.75 to 5.5
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
3.67 hours
Interval 3.58 to 6.0
|
5.17 hours
Interval 4.08 to 5.5
|
SECONDARY outcome
Timeframe: Weeks 0-2 and 24-26Population: FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Clearance of Ofa Over the Course of Weeks 0-2 and 24-26
Weeks 0-2; n=8, 10, 6, 0, 0, 0
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
0.006 liters per hour
Geometric Coefficient of Variation 34.2
|
0.005 liters per hour
Geometric Coefficient of Variation 41.0
|
0.003 liters per hour
Geometric Coefficient of Variation 30.8
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
Clearance of Ofa Over the Course of Weeks 0-2 and 24-26
Weeks 24-26; n=0, 0, 0, 4, 3, 4
|
0.03 liters per hour
Geometric Coefficient of Variation 44.4
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA liters per hour
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
0.008 liters per hour
Geometric Coefficient of Variation 29.5
|
0.004 liters per hour
Geometric Coefficient of Variation 54.4
|
SECONDARY outcome
Timeframe: Weeks 0-2 and 24-26Population: FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
Weeks 0-2; n=8, 10, 6, 0, 0, 0
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
2.48 liters
Geometric Coefficient of Variation 20.4
|
2.61 liters
Geometric Coefficient of Variation 42.0
|
2.19 liters
Geometric Coefficient of Variation 21.3
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
|
The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26
Weeks 24-26; n=0, 0, 0, 4, 3, 4
|
2.15 liters
Geometric Coefficient of Variation 20.8
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA liters
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
2.74 liters
Geometric Coefficient of Variation 6.54
|
2.20 liters
Geometric Coefficient of Variation 68.0
|
SECONDARY outcome
Timeframe: Weeks 0-2 and 24-26Population: FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by "n=" in the category titles).
The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.
Outcome measures
| Measure |
Matching Placebo/700 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
|
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 Participants
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
300 mg Ofa/Matching Placebo
n=10 Participants
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
700 mg Ofa/Matching Placebo
n=6 Participants
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
|
Matching Placebo/100 mg Ofa
n=4 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
|
Matching Placebo/300 mg Ofa
n=3 Participants
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
|
|---|---|---|---|---|---|---|
|
Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
Weeks 24-26; n=0, 0, 0, 4, 3, 4
|
453 hours
Geometric Coefficient of Variation 49.9
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 4-6 during Treatment Period 2. Participants in Arms 1-3 received placebo during Treatment Period 2.
|
241 hours
Geometric Coefficient of Variation 23.6
|
342 hours
Geometric Coefficient of Variation 16.3
|
|
Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26
Weeks 0-2; n=8, 10, 6, 0, 0, 0
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
246 hours
Geometric Coefficient of Variation 16.1
|
331 hours
Geometric Coefficient of Variation 35.2
|
452 hours
Geometric Coefficient of Variation 28.4
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
NA hours
Geometric Coefficient of Variation NA
Ofa concentrations were only measured in Arms 1-3 during Treatment Period 1. Participants in Arms 4-6 received placebo during Treatment Period 1.
|
Adverse Events
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
300 mg Ofa/Matching Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
700 mg Ofa/Matching Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Matching Placebo/100 mg Ofa
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Matching Placebo/300 mg Ofa
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Matching Placebo/700 mg Ofa
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 participants at risk
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
300 mg Ofa/Matching Placebo
n=11 participants at risk
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
700 mg Ofa/Matching Placebo
n=7 participants at risk
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/100 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/300 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/700 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
Other adverse events
| Measure |
100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo
n=8 participants at risk
Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
300 mg Ofa/Matching Placebo
n=11 participants at risk
Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
700 mg Ofa/Matching Placebo
n=7 participants at risk
Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/100 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/300 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
Matching Placebo/700 mg Ofa
n=4 participants at risk
Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
27.3%
3/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
57.1%
4/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
2/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
18.2%
2/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
75.0%
3/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
4/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Tracheobronchitis
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Viral infection
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
27.3%
3/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Varicella
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
37.5%
3/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
36.4%
4/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
28.6%
2/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Burning sensation
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
18.2%
2/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Gastrointestinal disorders
Neck pain
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Psychiatric disorders
Depression
|
25.0%
2/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
18.2%
2/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Eye disorders
Abnormal sensation in eye
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Investigations
False positive laboratory result
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Investigations
Blood bicarbonate decreased
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Skin and subcutaneous tissue disorders
Anemia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
9.1%
1/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Hypoaesthesia facial
|
12.5%
1/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Nervous system disorders
Oropharyngeal pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal edema
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
14.3%
1/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
50.0%
2/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Surgical and medical procedures
Bartholin's cyst removal
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
|
Surgical and medical procedures
Antibiotic prophylaxis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/11 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/7 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
25.0%
1/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-serious AEs are reported for both the first period (FP; Weeks 0-24) and the second period (SP; Weeks 24-48). SAEs were collected during the IFUP (collected/reported up to Week 104); however, non-serious AEs were not.
The duration of B-cell depletion observed following ofatumumab administration makes attribution of an SAE/AE in the SP to placebo versus ofatumumab difficult. Because it may not be appropriate to ascribe events reported in the SP to placebo, SAEs/AEs are reported by treatment sequence rather than by each individual treatment received.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER