NCT02709512 · ADVERSE EVENTS

Adverse events

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin · Source last updated 2023-10-04

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: Treatment-emergent AEs were collected with onset after the first dose of study drug or existing events that worsened after the first dose during the study, approximately 18 months.
Other-event reporting threshold: 2.5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Drug: ADI-PEG 20 Plus Pem Platinum Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication	19 / 125	106 / 125	62 / 125
Drug: Placebo Plus Pem Platinum Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication	20 / 124	111 / 124	61 / 124

Group identifiers: EG000: Drug: ADI-PEG 20 Plus Pem Platinum · EG001: Drug: Placebo Plus Pem Platinum

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
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
125
num Events
19
group Id
EG001
num Affected
6
num At Risk
124
num Events
20
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
125
num Events
15
group Id
EG001
num Affected
8
num At Risk
124
num Events
11
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
9
group Id
EG001
num Affected
7
num At Risk
124
num Events
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
125
num Events
10
group Id
EG001
num Affected
2
num At Risk
124
num Events
7
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
125
num Events
9
group Id
EG001
num Affected
0
num At Risk
124
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
125
num Events
6
group Id
EG001
num Affected
4
num At Risk
124
num Events
4
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
5
num At Risk
124
num Events
6
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
3
num At Risk
124
num Events
5
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
2
group Id
EG001
num Affected
3
num At Risk
124
num Events
7
term
Musculoskeletal Testing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
3
group Id
EG001
num Affected
3
num At Risk
124
num Events
6
term
Cerebrovascular Accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
125
num Events
5
group Id
EG001
num Affected
1
num At Risk
124
num Events
2
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
2
num At Risk
124
num Events
4
term
Alanine aminotransferase increased

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
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
65
num At Risk
125
num Events
106
group Id
EG001
num Affected
67
num At Risk
124
num Events
111
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
66
num At Risk
125
num Events
106
group Id
EG001
num Affected
62
num At Risk
124
num Events
111
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
54
num At Risk
125
num Events
106
group Id
EG001
num Affected
41
num At Risk
124
num Events
111
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
34
num At Risk
125
num Events
106
group Id
EG001
num Affected
38
num At Risk
124
num Events
111
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
26
num At Risk
125
num Events
106
group Id
EG001
num Affected
44
num At Risk
124
num Events
111
term
Decreased Appetite

Complete source fields

event Groups

deaths Num Affected
62
deaths Num At Risk
125
description
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
id
EG000
other Num Affected
106
other Num At Risk
125
serious Num Affected
19
serious Num At Risk
125
title
Drug: ADI-PEG 20 Plus Pem Platinum
deaths Num Affected
61
deaths Num At Risk
124
description
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
id
EG001
other Num Affected
111
other Num At Risk
124
serious Num Affected
20
serious Num At Risk
124
title
Drug: Placebo Plus Pem Platinum

frequency Threshold

2.5

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
65
num At Risk
125
num Events
106
group Id
EG001
num Affected
67
num At Risk
124
num Events
111
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
66
num At Risk
125
num Events
106
group Id
EG001
num Affected
62
num At Risk
124
num Events
111
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
54
num At Risk
125
num Events
106
group Id
EG001
num Affected
41
num At Risk
124
num Events
111
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
34
num At Risk
125
num Events
106
group Id
EG001
num Affected
38
num At Risk
124
num Events
111
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
26
num At Risk
125
num Events
106
group Id
EG001
num Affected
44
num At Risk
124
num Events
111
term
Decreased Appetite

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
125
num Events
19
group Id
EG001
num Affected
6
num At Risk
124
num Events
20
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
125
num Events
15
group Id
EG001
num Affected
8
num At Risk
124
num Events
11
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
9
group Id
EG001
num Affected
7
num At Risk
124
num Events
16
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
125
num Events
10
group Id
EG001
num Affected
2
num At Risk
124
num Events
7
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
125
num Events
9
group Id
EG001
num Affected
0
num At Risk
124
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
6
num At Risk
125
num Events
6
group Id
EG001
num Affected
4
num At Risk
124
num Events
4
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
5
num At Risk
124
num Events
6
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
3
num At Risk
124
num Events
5
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
2
group Id
EG001
num Affected
3
num At Risk
124
num Events
7
term
Musculoskeletal Testing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
125
num Events
3
group Id
EG001
num Affected
3
num At Risk
124
num Events
6
term
Cerebrovascular Accident
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
125
num Events
5
group Id
EG001
num Affected
1
num At Risk
124
num Events
2
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
125
num Events
0
group Id
EG001
num Affected
2
num At Risk
124
num Events
4
term
Alanine aminotransferase increased

time Frame

Treatment-emergent AEs were collected with onset after the first dose of study drug or existing events that worsened after the first dose during the study, approximately 18 months.

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