NCT03644550 · ADVERSE EVENTS

Adverse events

Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma · Source last updated 2021-12-02

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: Date treatment consent signed to date off study, approximately 22 months and 29 days.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
1/LMB- 100+Pembrolizumab LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles. LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1. LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial). Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.	14 / 18	18 / 18	9 / 18

Group identifiers: EG000: 1/LMB- 100+Pembrolizumab

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
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal pain
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
18
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Capillary leak syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Dyspnea
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
18
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Nausea

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
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
9
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
14
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
14
num At Risk
18
num Events
21
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
18
num Events
14
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
17
num At Risk
18
num Events
109
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
9
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
13
num At Risk
18
num Events
24
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
7
term
Back pain

Complete source fields

event Groups

deaths Num Affected
9
deaths Num At Risk
18
description
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles. LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1. LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial). Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
id
EG000
other Num Affected
18
other Num At Risk
18
serious Num Affected
14
serious Num At Risk
18
title
1/LMB- 100+Pembrolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
9
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
14
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
14
num At Risk
18
num Events
21
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
18
num Events
14
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
17
num At Risk
18
num Events
109
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
7
num At Risk
18
num Events
9
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
13
num At Risk
18
num Events
24
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
7
term
Back pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal pain
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
18
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Capillary leak syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Dyspnea
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
18
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Nausea

time Frame

Date treatment consent signed to date off study, approximately 22 months and 29 days.

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Preserved source evidence · Not medical advice