NCT00811733 · OUTCOME
Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia · Source last updated 2017-05-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure NUMBER
Unit participants
Interval / dispersion Not reported
Time frame From baseline up to approximately 5 years What was measured An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug.
Analysis population: Safety Population. Only those participants who experienced a study drug-related AE were assessed.
Groups in this outcome 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
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 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 13 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 22
Reported measurements Pruritus Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 4 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 8 Not reported Not reported Not reported Not reported
Urticaria Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 4 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 9 Not reported Not reported Not reported Not reported
Rash Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 4 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 3 Not reported Not reported Not reported Not reported
Pruritus generalised Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Hyperhidrosis Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Erythema Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Palmar erythema Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Rash macular Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Swelling face Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Throat irritation Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 7 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 3 Not reported Not reported Not reported Not reported
Nasal congestion Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Oropharyngeal pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 3 Not reported Not reported Not reported Not reported
Dyspnoea Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Epistaxis Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Painful respiration Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Pulmonary oedema Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Rhinitis allergic Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Rhinorrhoea Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Sneezing Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Pyrexia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 5 Not reported Not reported Not reported Not reported
Chills Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 5 Not reported Not reported Not reported Not reported
Chest pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Chest discomfort Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Fatigue Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Non-cardiac chest pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Asthenia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Ill-defined disorder Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Local swelling Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Malaise Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Abdominal pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Diarrhoea Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 3 Not reported Not reported Not reported Not reported
Nausea Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Paraesthesia oral Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Abdominal discomfort Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Dyspepsia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Hypoaesthesia oral Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Lip swelling Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Oral pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Oral pruritus Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Stomatitis Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Flushing Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 6 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 4 Not reported Not reported Not reported Not reported
Hypotension Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Back pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Limb discomfort Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Muscle spasms Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Musculoskeletal pain Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Myalgia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Trismus Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Anaemia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Haemolysis Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Leukopenia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 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 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Neutropenia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Ear pruritus Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 3 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Eye pruritus Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 3 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Ocular hyperaemia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Abnormal sensation in eye Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Eye swelling Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Decreased appetite Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Fluid overload Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Hypophagia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Increased appetite Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Headache Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Paraesthesia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 2 Not reported Not reported Not reported Not reported
Sinus headache Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Infusion related reaction Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 2 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 3 Not reported Not reported Not reported Not reported
Blood creatinine increased Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Body temperature increased Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Protein total increased Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Hypersensitivity Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Serum sickness Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Rhinitis Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Urinary tract infection Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Bradycardia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Insomnia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Renal failure acute Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Thirst Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Vomiting Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Cryoglobulinaemia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Pallor Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Arthralgia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Fluid retention Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Hypoaesthesia Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Psychomotor hyperactivity Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 0 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 1 Not reported Not reported Not reported Not reported
Weight decreased Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 1 Not reported Not reported Not reported Not reported 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 4
group Id OG001
value 8
title Pruritus categories measurements
group Id OG000
value 4
group Id OG001
value 9
title Urticaria categories measurements
group Id OG000
value 4
group Id OG001
value 3
title Rash categories measurements
group Id OG000
value 2
group Id OG001
value 1
title Pruritus generalised categories measurements
group Id OG000
value 1
group Id OG001
value 1
title Hyperhidrosis categories measurements
group Id OG000
value 1
group Id OG001
value 0
title Erythema categories measurements
group Id OG000
value 0
group Id OG001
value 1
title Palmar erythema categories measurements
group Id OG000
value 1
group Id OG001
value 0
title Rash macular categories measurements
group Id OG000
value 0
group Id OG001
value 1
title Swelling face categories measurements
group Id OG000
value 7
group Id OG001
value 3
title Throat irritation categories measurements
group Id OG000
value 1
group Id OG001
value 2
title Nasal congestion categories measurements
group Id OG000
value 0
group Id OG001
value 3
title Oropharyngeal pain Show more (12 of 86) denoms counts
group Id OG000
value 13
group Id OG001
value 22
units Participants
description An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug. groups
description Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
id OG000
title 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
description Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
id OG001
title 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
param Type NUMBER
population Description Safety Population. Only those participants who experienced a study drug-related AE were assessed.
reporting Status POSTED
time Frame From baseline up to approximately 5 years
title Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug
type SECONDARY
unit Of Measure participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle