NCT02611037 · ADVERSE EVENTS

Adverse events

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma · Source last updated 2025-12-18

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 were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Chemoperfusion - Lead In Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.	2 / 5	5 / 5	2 / 5
Chemoperfusion - Open Label Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA	7 / 25	25 / 25	21 / 25

Group identifiers: EG000: Chemoperfusion - Lead In · EG001: Chemoperfusion - Open Label

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
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
25
num Events
2
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
3
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
5
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Dyspena
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
2
group Id
EG001
num Affected
1
num At Risk
25
num Events
3
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Thromboembolic event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
2
term
Esophageal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Stroke

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
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
4
num At Risk
5
num Events
11
group Id
EG001
num Affected
16
num At Risk
25
num Events
46
term
Chest wall pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
5
num At Risk
25
num Events
6
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
3
num At Risk
25
num Events
4
term
Back Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
25
num Events
2
term
Generalized muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
3
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Flank pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
8
group Id
EG001
num Affected
12
num At Risk
25
num Events
33
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
5
num At Risk
5
num Events
7
group Id
EG001
num Affected
8
num At Risk
25
num Events
10
term
Hyperkalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
4
group Id
EG001
num Affected
4
num At Risk
25
num Events
12
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
3
num At Risk
25
num Events
8
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
4
num At Risk
25
num Events
4
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
3
group Id
EG001
num Affected
3
num At Risk
25
num Events
3
term
Hypercalcemia

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
5
description
Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m\^2). Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Chemoperfusion - Lead In
deaths Num Affected
21
deaths Num At Risk
25
description
Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Cisplatin: The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m\^2 body surface area (BSA). Methotrexate: The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m\^2 BSA. Gemcitabine: The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m\^2 BSA
id
EG001
other Num Affected
25
other Num At Risk
25
serious Num Affected
7
serious Num At Risk
25
title
Chemoperfusion - Open Label

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
4
num At Risk
5
num Events
11
group Id
EG001
num Affected
16
num At Risk
25
num Events
46
term
Chest wall pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
5
num At Risk
25
num Events
6
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
3
num At Risk
25
num Events
4
term
Back Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
25
num Events
2
term
Generalized muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
3
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Flank pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
8
group Id
EG001
num Affected
12
num At Risk
25
num Events
33
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
5
num At Risk
5
num Events
7
group Id
EG001
num Affected
8
num At Risk
25
num Events
10
term
Hyperkalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
4
group Id
EG001
num Affected
4
num At Risk
25
num Events
12
term
Hyponatremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
5
num Events
3
group Id
EG001
num Affected
3
num At Risk
25
num Events
8
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
4
num At Risk
25
num Events
4
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
3
group Id
EG001
num Affected
3
num At Risk
25
num Events
3
term
Hypercalcemia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
25
num Events
2
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
3
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
5
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Dyspena
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
2
group Id
EG001
num Affected
1
num At Risk
25
num Events
3
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Thromboembolic event
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
1
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
25
num Events
2
term
Esophageal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
25
num Events
0
term
Stroke

time Frame

Adverse Events were collected from the first day of treatment until 30 days after last date of treatment, an average of 7.8 months.

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

Preserved source evidence · Not medical advice