NCT01678443 · ADVERSE EVENTS

Adverse events

Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies · Source last updated 2021-04-02

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: AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant	0 / 2	2 / 2	Not reported / Not reported

Group identifiers: EG000: Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)

Serious adverse events

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

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
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hyperglycemia

Complete source fields

event Groups

description
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hyperglycemia

time Frame

AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician

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

Preserved source evidence · Not medical advice