NCT00135200 · ADVERSE EVENTS

Adverse events

Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma · Source last updated 2025-04-30

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bexxar Therapeutic The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.	3 / 16	15 / 16	Not reported / Not reported

Group identifiers: EG000: Bexxar Therapeutic

Serious adverse events

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

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Infection with Normal Neutrophil Count
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Infection wtih Unknown Neutrophil Count
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Neuropathy - Motor

Other reported adverse events

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

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Hemoglobin
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
16
num Events
7
term
Leukocytes (total WBC)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
16
num Events
5
term
Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
16
num Events
10
term
Neutrophils/granulocytes (ANC/AGC)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
16
num Events
12
term
Platelets
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Fatigue (asthenia, lethargy, malaise)
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
4
term
Rash/desquamation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Flatulence
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Nausea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Infection with normal ANC or Grade 1 or 2 neutrophils
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Phosphate, serum-low (hypophosphatemia)

Complete source fields

event Groups

description
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.
id
EG000
other Num Affected
15
other Num At Risk
16
serious Num Affected
3
serious Num At Risk
16
title
Bexxar Therapeutic

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Hemoglobin
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
16
num Events
7
term
Leukocytes (total WBC)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
16
num Events
5
term
Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
16
num Events
10
term
Neutrophils/granulocytes (ANC/AGC)
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
16
num Events
12
term
Platelets
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Fatigue (asthenia, lethargy, malaise)
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
4
term
Rash/desquamation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Flatulence
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Nausea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Infection with normal ANC or Grade 1 or 2 neutrophils
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Phosphate, serum-low (hypophosphatemia)

serious Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Infection with Normal Neutrophil Count
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Infection wtih Unknown Neutrophil Count
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Neuropathy - Motor

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Preserved source evidence · Not medical advice