NCT00458822 · ADVERSE EVENTS

Adverse events

Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis · Source last updated 2016-08-10

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
All Patients All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis	20 / 40	40 / 40	Not reported / Not reported

Group identifiers: EG000: All Patients

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
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Arthritis (non-septic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
CNS cerebrovascular ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Cardiac Arrhythmia, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
num Events
6
term
Cardiac General, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
num Events
2
term
Coagulation, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Conduction Abnormality NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
num Events
3
term
Death not associated with CTCAE term- Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
num Events
4
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Fever (in the absence of neutropenia)

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
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
31
num At Risk
40
term
Albumin, low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
9
num At Risk
40
term
Alkaline phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
11
num At Risk
40
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
AST, SGOT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
5
num At Risk
40
term
Bicarbonate, serum-low
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
Cholesterol,high(hypercholestremia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
9
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
22
num At Risk
40
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
term
Cushingoid appearance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
term
Dehydration

Complete source fields

event Groups

description
All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
id
EG000
other Num Affected
40
other Num At Risk
40
serious Num Affected
20
serious Num At Risk
40
title
All Patients

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
31
num At Risk
40
term
Albumin, low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
9
num At Risk
40
term
Alkaline phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
11
num At Risk
40
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
AST, SGOT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
5
num At Risk
40
term
Bicarbonate, serum-low
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
term
Cholesterol,high(hypercholestremia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
9
num At Risk
40
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
22
num At Risk
40
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
term
Cushingoid appearance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
term
Dehydration

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Arthritis (non-septic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
CNS cerebrovascular ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Cardiac Arrhythmia, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
6
num At Risk
40
num Events
6
term
Cardiac General, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
40
num Events
2
term
Coagulation, other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Conduction Abnormality NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
num Events
3
term
Death not associated with CTCAE term- Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
40
num Events
4
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
40
num Events
1
term
Fever (in the absence of neutropenia)

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Preserved source evidence · Not medical advice