NCT03899805 · ADVERSE EVENTS

Adverse events

A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas · Source last updated 2025-08-28

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: Up to 2 years.
Other-event reporting threshold: 0%

A serious adverse event (SAE) is any adverse event occurring at any dose that, 1) results in death; 2) is life threatening; 3) results in persistent or significant disability/incapacity; 4) results in or prolongs an existing inpatient hospitalization; 5) is a congenital anomaly/birth defect; 6) is a new cancer (that is not a condition of the study); 7) is associated with an overdose; 8) is another important medical event

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Liposarcomas * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.	9 / 20	20 / 20	10 / 20
Leiomyosarcomas * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.	8 / 19	19 / 19	12 / 19
Undifferentiated Pleomorphic Sarcomas * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.	8 / 18	18 / 18	8 / 18

Group identifiers: EG000: Liposarcomas · EG001: Leiomyosarcomas · EG002: Undifferentiated Pleomorphic Sarcomas

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
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Fatigue

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
CTCAE (5.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
19
num At Risk
19
group Id
EG002
num Affected
18
num At Risk
18
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
2
num At Risk
18
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
2
num At Risk
18
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
9
num At Risk
18
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Ventricular tachycardia

Complete source fields

description

event Groups

deaths Num Affected
10
deaths Num At Risk
20
description
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
9
serious Num At Risk
20
title
Liposarcomas
deaths Num Affected
12
deaths Num At Risk
19
description
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
id
EG001
other Num Affected
19
other Num At Risk
19
serious Num Affected
8
serious Num At Risk
19
title
Leiomyosarcomas
deaths Num Affected
8
deaths Num At Risk
18
description
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
id
EG002
other Num Affected
18
other Num At Risk
18
serious Num Affected
8
serious Num At Risk
18
title
Undifferentiated Pleomorphic Sarcomas

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
20
num At Risk
20
group Id
EG001
num Affected
19
num At Risk
19
group Id
EG002
num Affected
18
num At Risk
18
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
2
num At Risk
18
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
2
num At Risk
18
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
9
num At Risk
18
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Ventricular tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
3
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
1
num At Risk
18
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
19
group Id
EG002
num Affected
0
num At Risk
18
term
Fatigue

time Frame

Up to 2 years.

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

Preserved source evidence · Not medical advice