NCT02780609 · ADVERSE EVENTS

Adverse events

Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma · Source last updated 2022-11-04

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: Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1 Level 1: Selinexor Plus HDM HCT 40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.	3 / 3	3 / 3	2 / 3
Phase 1 Level 2: Selinexor Plus HDM HCT 60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.	2 / 3	2 / 3	0 / 3
Phase 1 Level 3: Selinexor Plus HDM HCT 80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.	3 / 6	6 / 6	2 / 6
Phase 2: Selinexor Plus HDM HCT 80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.	5 / 10	10 / 10	0 / 10

Group identifiers: EG000: Phase 1 Level 1: Selinexor Plus HDM HCT · EG001: Phase 1 Level 2: Selinexor Plus HDM HCT · EG002: Phase 1 Level 3: Selinexor Plus HDM HCT · EG003: Phase 2: Selinexor Plus HDM HCT

Serious 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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
10
num Events
5
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Neck edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Thromboembolic event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Lung infection

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
10
num Events
8
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
5
num At Risk
10
num Events
5
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
8
num At Risk
10
num Events
17
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
10
num At Risk
10
num Events
27
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
10
num At Risk
10
num Events
28
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase 1 Level 1: Selinexor Plus HDM HCT
deaths Num Affected
0
deaths Num At Risk
3
description
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
id
EG001
other Num Affected
2
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1 Level 2: Selinexor Plus HDM HCT
deaths Num Affected
2
deaths Num At Risk
6
description
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1 Level 3: Selinexor Plus HDM HCT
deaths Num Affected
0
deaths Num At Risk
10
description
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
Phase 2: Selinexor Plus HDM HCT

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
10
num Events
8
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Dizziness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
5
num At Risk
10
num Events
5
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
8
num At Risk
10
num Events
17
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
10
num At Risk
10
num Events
27
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
10
num At Risk
10
num Events
28
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
3
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
10
num Events
5
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
2
num At Risk
10
num Events
2
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Neck edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Thromboembolic event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
term
Lung infection

time Frame

Adverse events collected from date on study to 30 days after last treatment date, a total of 3 years and 8 months.

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

Preserved source evidence · Not medical advice