NCT00600353 · ADVERSE EVENTS

Adverse events

Multi-day Doses in Prevention of Nausea and Emesis · Source last updated 2017-03-09

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: Day +30
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Subjects With Multiple Myeloma Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion	0 / 9	3 / 9	Not reported / Not reported
Patients With Lymphoma Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant	0 / 9	2 / 9	Not reported / Not reported

Group identifiers: EG000: Subjects With Multiple Myeloma · EG001: Patients With Lymphoma

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Infection, Abdomen NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Gastric Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Gallbladder pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Conduction disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection, Catheter-related

Complete source fields

event Groups

description
Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
id
EG000
other Num Affected
3
other Num At Risk
9
serious Num Affected
0
serious Num At Risk
9
title
Subjects With Multiple Myeloma
description
Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
id
EG001
other Num Affected
2
other Num At Risk
9
serious Num Affected
0
serious Num At Risk
9
title
Patients With Lymphoma

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Infection, Abdomen NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Gastric Mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Gallbladder pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
9
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Conduction disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection, Catheter-related

time Frame

Day +30

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

Preserved source evidence · Not medical advice