NCT03245450 · ADVERSE EVENTS

Adverse events

Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors · Source last updated 2022-06-28

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: From first dose of study drug up to approximately 2 year 4 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.	1 / 3	3 / 3	1 / 3
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.	3 / 4	4 / 4	2 / 4
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.	0 / 3	3 / 3	1 / 3
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.	1 / 3	3 / 3	1 / 3
Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.	5 / 9	9 / 9	4 / 9
Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.	4 / 9	9 / 9	3 / 9
Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.	3 / 9	9 / 9	3 / 9

Group identifiers: EG000: Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2 · EG001: Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 · EG002: Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2 · EG003: Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2 · EG004: Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 · EG005: Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 · EG006: Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 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
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
9
num Events
2
group Id
EG005
num Affected
2
num At Risk
9
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malnutrition
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
1
num At Risk
9
num Events
2
term
Pain in jaw
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
2
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malignant pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Dyspnoea

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 24.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
4
num Events
14
group Id
EG002
num Affected
1
num At Risk
3
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
3
num At Risk
9
num Events
9
group Id
EG005
num Affected
4
num At Risk
9
num Events
8
group Id
EG006
num Affected
5
num At Risk
9
num Events
29
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
4
group Id
EG001
num Affected
1
num At Risk
4
num Events
14
group Id
EG002
num Affected
2
num At Risk
3
num Events
15
group Id
EG003
num Affected
1
num At Risk
3
num Events
12
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
3
num At Risk
9
num Events
32
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
3
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
39
group Id
EG001
num Affected
2
num At Risk
4
num Events
8
group Id
EG002
num Affected
3
num At Risk
3
num Events
18
group Id
EG003
num Affected
1
num At Risk
3
num Events
12
group Id
EG004
num Affected
3
num At Risk
9
num Events
15
group Id
EG005
num Affected
2
num At Risk
9
num Events
10
group Id
EG006
num Affected
4
num At Risk
9
num Events
52
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
5
num At Risk
9
num Events
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
7
num At Risk
9
num Events
9
group Id
EG005
num Affected
2
num At Risk
9
num Events
3
group Id
EG006
num Affected
2
num At Risk
9
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
9
num Events
2
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
2
num At Risk
9
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
12
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
4
num At Risk
9
num Events
24
group Id
EG005
num Affected
5
num At Risk
9
num Events
11
group Id
EG006
num Affected
5
num At Risk
9
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
4
num At Risk
9
num Events
5
group Id
EG005
num Affected
6
num At Risk
9
num Events
8
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Toothache

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
deaths Num Affected
2
deaths Num At Risk
4
description
Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2
deaths Num Affected
4
deaths Num At Risk
9
description
Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
id
EG004
other Num Affected
9
other Num At Risk
9
serious Num Affected
5
serious Num At Risk
9
title
Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
deaths Num Affected
3
deaths Num At Risk
9
description
Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
id
EG005
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
deaths Num Affected
3
deaths Num At Risk
9
description
Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
id
EG006
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
4
num Events
14
group Id
EG002
num Affected
1
num At Risk
3
num Events
6
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
3
num At Risk
9
num Events
9
group Id
EG005
num Affected
4
num At Risk
9
num Events
8
group Id
EG006
num Affected
5
num At Risk
9
num Events
29
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
4
group Id
EG001
num Affected
1
num At Risk
4
num Events
14
group Id
EG002
num Affected
2
num At Risk
3
num Events
15
group Id
EG003
num Affected
1
num At Risk
3
num Events
12
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
3
num At Risk
9
num Events
32
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
3
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
39
group Id
EG001
num Affected
2
num At Risk
4
num Events
8
group Id
EG002
num Affected
3
num At Risk
3
num Events
18
group Id
EG003
num Affected
1
num At Risk
3
num Events
12
group Id
EG004
num Affected
3
num At Risk
9
num Events
15
group Id
EG005
num Affected
2
num At Risk
9
num Events
10
group Id
EG006
num Affected
4
num At Risk
9
num Events
52
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
3
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
5
num At Risk
9
num Events
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
7
num At Risk
9
num Events
9
group Id
EG005
num Affected
2
num At Risk
9
num Events
3
group Id
EG006
num Affected
2
num At Risk
9
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
9
num Events
2
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
2
num At Risk
9
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
12
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
4
num At Risk
9
num Events
24
group Id
EG005
num Affected
5
num At Risk
9
num Events
11
group Id
EG006
num Affected
5
num At Risk
9
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
4
num At Risk
9
num Events
5
group Id
EG005
num Affected
6
num At Risk
9
num Events
8
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Toothache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
9
num Events
2
group Id
EG005
num Affected
2
num At Risk
9
num Events
2
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malnutrition
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
9
num Events
0
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
1
num At Risk
9
num Events
2
term
Pain in jaw
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
2
group Id
EG005
num Affected
1
num At Risk
9
num Events
1
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Malignant pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
9
num Events
1
group Id
EG005
num Affected
0
num At Risk
9
num Events
0
group Id
EG006
num Affected
0
num At Risk
9
num Events
0
term
Dyspnoea

time Frame

From first dose of study drug up to approximately 2 year 4 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice