NCT02011113 · ADVERSE EVENTS

Adverse events

Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01

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: From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pomalidomide Plus Dexamethasone Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.	16 / 36	36 / 36	Not reported / Not reported

Group identifiers: EG000: Pomalidomide Plus Dexamethasone

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
5
num At Risk
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
36
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
5
num At Risk
36
term
PNEUMONIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PNEUMONIA PNEUMOCOCCAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
36
term
ASTHMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
HYPOXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PLEURAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
MULTI-ORGAN FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
DECREASED APPETITE

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
26
num At Risk
36
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
16
num At Risk
36
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
17
num At Risk
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
8
num At Risk
36
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
6
num At Risk
36
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
9
num At Risk
36
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
6
num At Risk
36
term
MALAISE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
4
num At Risk
36
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
9
num At Risk
36
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
NAUSEA

Complete source fields

event Groups

description
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
id
EG000
other Num Affected
36
other Num At Risk
36
serious Num Affected
16
serious Num At Risk
36
title
Pomalidomide Plus Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
26
num At Risk
36
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
16
num At Risk
36
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
17
num At Risk
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
8
num At Risk
36
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
6
num At Risk
36
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
9
num At Risk
36
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
OEDEMA PERIPHERAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
6
num At Risk
36
term
MALAISE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
4
num At Risk
36
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
9
num At Risk
36
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
36
term
NAUSEA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
5
num At Risk
36
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
36
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
5
num At Risk
36
term
PNEUMONIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PNEUMONIA PNEUMOCOCCAL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
36
term
ASTHMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
HYPOXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PLEURAL EFFUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
MULTI-ORGAN FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
36
term
DECREASED APPETITE

time Frame

From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off

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Preserved source evidence · Not medical advice