NCT00811733 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Participants were followed from baseline up to approximately 5 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	5 / 15	15 / 15	Not reported / Not reported
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.	7 / 22	20 / 22	Not reported / Not reported

Group identifiers: EG000: 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 · EG001: 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Catheter site haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Dyspnoea exertional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pulmonary oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Cardiac failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Throat irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
22
term
Oropharyngeal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Nasal congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Dysphonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Rhinorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
15
group Id
EG001
num Affected
8
num At Risk
22
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
15
group Id
EG001
num Affected
9
num At Risk
22
term
Urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pruritus generalised

Complete source fields

event 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
EG000
other Num Affected
15
other Num At Risk
15
serious Num Affected
5
serious Num At Risk
15
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
EG001
other Num Affected
20
other Num At Risk
22
serious Num Affected
7
serious Num At Risk
22
title
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Throat irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
5
num At Risk
22
term
Oropharyngeal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Nasal congestion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Dysphonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Rhinorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
15
group Id
EG001
num Affected
8
num At Risk
22
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
15
group Id
EG001
num Affected
9
num At Risk
22
term
Urticaria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
15
group Id
EG001
num Affected
3
num At Risk
22
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pruritus generalised

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Catheter site haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
2
num At Risk
22
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Dyspnoea exertional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
15
group Id
EG001
num Affected
0
num At Risk
22
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Pulmonary oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
15
group Id
EG001
num Affected
1
num At Risk
22
term
Cardiac failure

time Frame

Participants were followed from baseline up to approximately 5 years.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice