NCT00461045 · ADVERSE EVENTS

Adverse events

Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-12-19

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MRZ 0.5 mg/m^2 Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles	7 / 15	15 / 15	Not reported / Not reported

Group identifiers: EG000: MRZ 0.5 mg/m^2

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
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Renal failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Adverse Drug Reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Ischaemic Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Arthritis Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Endocarditis Bacterial

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
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
9
num At Risk
15
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Hallucination, Visual
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Mental status changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Upper respiratory tract infection

Complete source fields

event Groups

description
Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
id
EG000
other Num Affected
15
other Num At Risk
15
serious Num Affected
7
serious Num At Risk
15
title
MRZ 0.5 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
9
num At Risk
15
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Hallucination, Visual
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Mental status changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Upper respiratory tract infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Renal failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Adverse Drug Reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Ischaemic Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Arthritis Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (8.1)
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Endocarditis Bacterial

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