Trial Outcomes & Findings for Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant (NCT NCT00622388)
NCT ID: NCT00622388
Last Updated: 2015-07-24
Results Overview
Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
6-month period from start of treatment (up to Week 24)
Results posted on
2015-07-24
Participant Flow
Participant milestones
| Measure |
Ofatumumab
Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
Ofatumumab
Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
|
|---|---|
|
Overall Study
Disease Progression
|
47
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Participant Refusal
|
1
|
|
Overall Study
Death
|
3
|
|
Overall Study
Received Alternate Anticancer Therapy
|
8
|
|
Overall Study
Took Prohibited Medication
|
2
|
|
Overall Study
Withdrew Consent
|
1
|
|
Overall Study
Insurance Expired
|
1
|
Baseline Characteristics
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
76 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=5 Participants
|
|
Number of Participants with the Indicated Prior Therapy
Prior ASCT
|
25 participants
n=5 Participants
|
|
Number of Participants with the Indicated Prior Therapy
Ineligible for ASCT
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-month period from start of treatment (up to Week 24)Population: Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment
Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
Outcome measures
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Number of Participants With Objective Response
|
9 participants
|
PRIMARY outcome
Timeframe: 6-month period from start of treatment (up to Week 24)Population: FAS
According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.
Outcome measures
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
Responders with CR
|
2 participants
|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
Responders with PR
|
7 participants
|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
Non-responders with SD
|
14 participants
|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
Non-responders with PD
|
34 participants
|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
Non-responders with NE
|
24 participants
|
SECONDARY outcome
Timeframe: From date of start of treatment to 2 years or withdrawalPopulation: FAS. Only participants with CR or PR were analyzed.
The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
Outcome measures
| Measure |
Ofatumumab
n=9 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Duration of Response
|
9.5 months
Interval 5.4 to
Too few participants experienced the event to estimate the upper limit of the confidence interval.
|
SECONDARY outcome
Timeframe: From date of start of treatment to 2 years or withdrawalPopulation: FAS
PFS was defined as the time from treatment start until progression or death.
Outcome measures
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Progression-free Survival (PFS)
|
2.5 months
Interval 2.3 to 4.9
|
SECONDARY outcome
Timeframe: From date of start of treatment to 5 years or withdrawalPopulation: FAS
Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
Outcome measures
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
|
NA months
Interval 7.4 to
Too few participants experienced the event to estimate the median and the upper limit of the confidence interval.
|
SECONDARY outcome
Timeframe: From date of start of treatment to 5 years or withdrawalPopulation: FAS
Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)Population: FAS. Data are provided for the number of participants attending each visit.
HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.
Outcome measures
| Measure |
Ofatumumab
n=79 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Screening, n=79
|
0 participants
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Visit 12 (Month 6), n=20
|
0 participants
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Visit 13 (Month 9), n=16
|
0 participants
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Visit 14 (Month 12), n=16
|
0 participants
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Visit 18 (Month 24), n=8
|
0 participants
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
End of Trial/Withdrawal, n=43
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)Population: FAS. Data are provided for the number of participants attending each visit.
B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) \* 100.
Outcome measures
| Measure |
Ofatumumab
n=42 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 10 (Week 8), n=42
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 11 (Week 11), n=29
|
-100.0 percent change in cells
Interval -100.0 to 56.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 12 (Month 6), n=18
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 13 (Month 9), n=15
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 14 (Month 12), n=13
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 15 (Month 15), n=12
|
-60.7 percent change in cells
Interval -100.0 to 12.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 16 (Month 18), n=8
|
6.0 percent change in cells
Interval -88.0 to 179.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 17 (Month 21), n=8
|
-6.9 percent change in cells
Interval -58.0 to 56.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 18 (Month 24), n=7
|
-11.1 percent change in cells
Interval -100.0 to 50.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 19 (Month 30), n=2
|
80.8 percent change in cells
Interval 12.0 to 150.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD19+, Visit 20 (Month 36), n=2
|
68.6 percent change in cells
Interval -36.0 to 174.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 10 (Week 8), n=42
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 11 (Week 11), n=29
|
-100.0 percent change in cells
Interval -100.0 to 56.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 12 (Month 6), n=18
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 13 (Month 9), n=15
|
-100.0 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 14 (Month 12), n=13
|
-100 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 15 (Month 15), n=12
|
-57.3 percent change in cells
Interval -100.0 to 0.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 16 (Month 18), n=8
|
6.0 percent change in cells
Interval -88.0 to 171.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 17 (Month 21), n=8
|
-6.9 percent change in cells
Interval -58.0 to 28.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 18 (Month 24), n=5
|
-11.1 percent change in cells
Interval -100.0 to 50.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 19 (Month 30), n=2
|
75.2 percent change in cells
Interval 7.0 to 143.0
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
CD45+CD20+, Visit 20 (Month 36), n=2
|
68.6 percent change in cells
Interval -36.0 to 174.0
|
SECONDARY outcome
Timeframe: Time frame is from date of start of treatment to 2 years or withdrawalPopulation: FAS
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
Outcome measures
| Measure |
Ofatumumab
n=81 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
78 participants
|
SECONDARY outcome
Timeframe: Screening and post-baseline visits (last visit was to occur 24 months post first dose)Population: FAS
CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 9 (Week 7; up to 11 months after last dose)Population: FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
Outcome measures
| Measure |
Ofatumumab
n=46 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
AUC(0-inf), n=30
|
720388 micrograms*hour/milliliter (µg.h/mL)
Geometric Coefficient of Variation 79
|
|
AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
AUC(0-168), n=46
|
110193 micrograms*hour/milliliter (µg.h/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Visit 2 (Week 0) and Visit 9 (Week 7)Population: FAS. Data are provided for the number of participants attending each visit.
Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
Outcome measures
| Measure |
Ofatumumab
n=74 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
First infusion Cmax; 300 mg, n=74
|
109 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 42
|
|
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
Eighth infusion Cmax; 1000 mg, n=48
|
839 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24
|
|
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
Eighth infusion Ctrough; 1000 mg, n=48
|
497 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 34
|
SECONDARY outcome
Timeframe: Visit 9 (Week 7; up to 11 months after last dose)Population: FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.
t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
Outcome measures
| Measure |
Ofatumumab
n=30 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Half-life (T1/2) for Ofatumumab at the Eighth Infusion
|
637 hours
Geometric Coefficient of Variation 51
|
SECONDARY outcome
Timeframe: Visit 9 (Week 7; up to 11 months after last dose)Population: FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.
CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
Outcome measures
| Measure |
Ofatumumab
n=46 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Clearance (CL) of Ofatumumab at the Eighth Infusion
|
9.1 milliliters per hour (mL/h)
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Visit 9 (Week 7; up to 11 months after the last dose)Population: FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.
Vss is the volume of distribution at steady state of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=30 Participants
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
|
8.3 liters
Geometric Coefficient of Variation 45
|
Adverse Events
Ofatumumab
Serious events: 33 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ofatumumab
n=81 participants at risk
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
General disorders
Disease progression
|
9.9%
8/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Pyrexia
|
2.5%
2/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Infusion related reaction
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Multi-organ failure
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
3/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
2/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
2/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Bronchitis
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Central line infection
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Pneumonia
|
2.5%
2/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Sepsis
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Septic shock
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Nervous system disorders
Neurological symptom
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Nervous system disorders
Paraparesis
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Renal and urinary disorders
Renal failure
|
2.5%
2/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Endocrine disorders
Eyelid ptosis
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Immune system disorders
Anaphylactic reaction
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
Other adverse events
| Measure |
Ofatumumab
n=81 participants at risk
Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
15/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.6%
11/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Constipation
|
13.6%
11/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Nausea
|
12.3%
10/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Fatigue
|
16.0%
13/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Oedema peripheral
|
17.3%
14/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Pyrexia
|
11.1%
9/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Asthenia
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
General disorders
Disease progression
|
9.9%
8/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
8/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.9%
8/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.8%
12/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
10/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
9/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.6%
7/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.6%
7/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
7/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Nervous system disorders
Headache
|
6.2%
5/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Investigations
Blood creatinine increased
|
6.2%
5/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Metabolism and nutrition disorders
Anorexia
|
9.9%
8/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Immune system disorders
Hypersensitivity
|
7.4%
6/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
5/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
5/81 • Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
|
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