Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma · Source last updated 2021-05-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to two years
What was measured
Toxicities will be graded according to the NCI CTCAE v4.0.
Groups in this outcome
Ofatumumab + Fresh Frozen Plasma
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Ofatumumab + Fresh Frozen Plasma
12
Reported measurements
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Chills
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Cough
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Dyspepsia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
3
Not reported
Not reported
Not reported
Not reported
Blepharitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
5
Not reported
Not reported
Not reported
Not reported
Flushing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Gastroesophageal reflux disease
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Feverish
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Generalized muscle weakness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Headache
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
4
Not reported
Not reported
Not reported
Not reported
Hiccups
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
hyponatremia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Infusion related reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
7
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Lymph node pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
5
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
4
Not reported
Not reported
Not reported
Not reported
Palpitations
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Paresthesia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
peripheral sensory neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
4
Not reported
Not reported
Not reported
Not reported
Rash acneiform
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Aspergillus Pneumonia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Sinus tachycardia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Sinusitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
2
Not reported
Not reported
Not reported
Not reported
Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Lesions on face, neck, scalp
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Guttate Psoriasis (Exacerbation of Symptoms)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Skin infection, Eyelid
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
4
Not reported
Not reported
Not reported
Not reported
Upper respiratory infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
Wheezing
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Ofatumumab + Fresh Frozen Plasma
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
title
Blood bilirubin increased
categories
measurements
group Id
OG000
value
1
title
Chills
categories
measurements
group Id
OG000
value
1
title
Constipation
categories
measurements
group Id
OG000
value
1
title
Cough
categories
measurements
group Id
OG000
value
2
title
Creatinine increased
categories
measurements
group Id
OG000
value
1
title
Dehydration
categories
measurements
group Id
OG000
value
2
title
Dizziness
categories
measurements
group Id
OG000
value
1
title
Dyspepsia
categories
measurements
group Id
OG000
value
3
title
Dyspnea
categories
measurements
group Id
OG000
value
1
title
Blepharitis
categories
measurements
group Id
OG000
value
5
title
Fatigue
categories
measurements
group Id
OG000
value
1
title
Flushing
denoms
counts
group Id
OG000
value
12
units
Participants
description
Toxicities will be graded according to the NCI CTCAE v4.0.
groups
description
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
Triangle