NCT01098266 · ADVERSE EVENTS

Adverse events

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed · Source last updated 2019-09-17

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: Through study completation, an average of 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
A: NGR-hTNF + BIC NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)	56 / 193	190 / 193	12 / 193
B: Placebo+BIC Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)	54 / 193	185 / 193	13 / 193

Group identifiers: EG000: A: NGR-hTNF + BIC · EG001: B: Placebo+BIC

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Paraneoplastic fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Brain mets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Brain mets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
group Id
EG001
num Affected
1
num At Risk
193
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
2
num At Risk
193
num Events
2
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
3
group Id
EG001
num Affected
2
num At Risk
193
num Events
2
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
group Id
EG001
num Affected
0
num At Risk
193
term
Hyperpyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Ischaemic ulcer to left heel
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
3
group Id
EG001
num Affected
3
num At Risk
193
num Events
3
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Deterioration of clinical status
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Admitted for pain control

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
Vascular disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
16
group Id
EG001
num Affected
12
num At Risk
193
num Events
15
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
12
group Id
EG001
num Affected
7
num At Risk
193
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
57
num At Risk
193
num Events
162
group Id
EG001
num Affected
60
num At Risk
193
num Events
119
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
34
num At Risk
193
num Events
58
group Id
EG001
num Affected
42
num At Risk
193
num Events
79
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
26
num At Risk
193
num Events
56
group Id
EG001
num Affected
23
num At Risk
193
num Events
47
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
24
num At Risk
193
num Events
85
group Id
EG001
num Affected
20
num At Risk
193
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
63
num At Risk
193
num Events
94
group Id
EG001
num Affected
56
num At Risk
193
num Events
80
term
Dysponoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
39
num At Risk
193
num Events
59
group Id
EG001
num Affected
47
num At Risk
193
num Events
71
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
12
group Id
EG001
num Affected
12
num At Risk
193
num Events
14
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
10
group Id
EG001
num Affected
6
num At Risk
193
num Events
7
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
15
num At Risk
193
num Events
16
group Id
EG001
num Affected
13
num At Risk
193
num Events
15
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
20
group Id
EG001
num Affected
12
num At Risk
193
num Events
15
term
Pheripheral neuropathy

Complete source fields

event Groups

deaths Num Affected
12
deaths Num At Risk
193
description
NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
id
EG000
other Num Affected
190
other Num At Risk
193
serious Num Affected
56
serious Num At Risk
193
title
A: NGR-hTNF + BIC
deaths Num Affected
13
deaths Num At Risk
193
description
Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
id
EG001
other Num Affected
185
other Num At Risk
193
serious Num Affected
54
serious Num At Risk
193
title
B: Placebo+BIC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
16
group Id
EG001
num Affected
12
num At Risk
193
num Events
15
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
12
group Id
EG001
num Affected
7
num At Risk
193
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
57
num At Risk
193
num Events
162
group Id
EG001
num Affected
60
num At Risk
193
num Events
119
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
34
num At Risk
193
num Events
58
group Id
EG001
num Affected
42
num At Risk
193
num Events
79
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
26
num At Risk
193
num Events
56
group Id
EG001
num Affected
23
num At Risk
193
num Events
47
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
24
num At Risk
193
num Events
85
group Id
EG001
num Affected
20
num At Risk
193
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
63
num At Risk
193
num Events
94
group Id
EG001
num Affected
56
num At Risk
193
num Events
80
term
Dysponoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
39
num At Risk
193
num Events
59
group Id
EG001
num Affected
47
num At Risk
193
num Events
71
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
12
group Id
EG001
num Affected
12
num At Risk
193
num Events
14
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
10
group Id
EG001
num Affected
6
num At Risk
193
num Events
7
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
15
num At Risk
193
num Events
16
group Id
EG001
num Affected
13
num At Risk
193
num Events
15
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
20
group Id
EG001
num Affected
12
num At Risk
193
num Events
15
term
Pheripheral neuropathy

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Paraneoplastic fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Brain mets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Brain mets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
group Id
EG001
num Affected
1
num At Risk
193
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
193
num Events
2
group Id
EG001
num Affected
2
num At Risk
193
num Events
2
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
3
group Id
EG001
num Affected
2
num At Risk
193
num Events
2
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
group Id
EG001
num Affected
0
num At Risk
193
term
Hyperpyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Ischaemic ulcer to left heel
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
3
group Id
EG001
num Affected
3
num At Risk
193
num Events
3
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
term
Deterioration of clinical status
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
term
Admitted for pain control

time Frame

Through study completation, an average of 2 years

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Preserved source evidence · Not medical advice