NCT02314247 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma · Source last updated 2023-01-26

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 of onset after the first dose of study treatment through 30 days following the last dose of study treatment.
Other-event reporting threshold: 0%

All patients who received at least 1 dose of study treatment were included in the Safety Population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Selinexor (PTCL) Assigned to 60 mg; 6 doses/cycle	8 / 9	9 / 9	3 / 9
Selinexor (CTCL) Assigned to 60 mg; 6 doses/cycle (6 patients) Assigned to 60 mg; 8 doses/cycle (1 patient)	1 / 7	7 / 7	1 / 7

Group identifiers: EG000: Selinexor (PTCL) · EG001: Selinexor (CTCL)

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 (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Wound Infection Staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Aphasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Pulmonary Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Rectal Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Fall

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
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Gastroesophageal Reflux Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
7
term
Decreased Appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Abnormal Loss of Weight
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Hypophosphataemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia

Complete source fields

description

All patients who received at least 1 dose of study treatment were included in the Safety Population.

event Groups

deaths Num Affected
3
deaths Num At Risk
9
description
Assigned to 60 mg; 6 doses/cycle
id
EG000
other Num Affected
9
other Num At Risk
9
serious Num Affected
8
serious Num At Risk
9
title
Selinexor (PTCL)
deaths Num Affected
1
deaths Num At Risk
7
description
Assigned to 60 mg; 6 doses/cycle (6 patients) Assigned to 60 mg; 8 doses/cycle (1 patient)
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Selinexor (CTCL)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
4
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Gastroesophageal Reflux Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
7
term
Decreased Appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Abnormal Loss of Weight
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Hypokalaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Hypophosphataemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Wound Infection Staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Aphasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Lethargy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Pulmonary Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
7
term
Rectal Haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
7
term
Fall

time Frame

Day of onset after the first dose of study treatment through 30 days following the last dose of study treatment.

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Preserved source evidence · Not medical advice