NCT04840615 · ADVERSE EVENTS
Adverse events
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 7 months.
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Dose Level 1: 400 mcg LMB-100 | 2 / 2 | 2 / 2 | 2 / 2 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Lung infection
- 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
- 2
- num Events
- 1
- term
- Pericardial tamponade
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Activated partial thromboplastin time prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 5
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Allergic reaction
- 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
- 2
- num Events
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 6
- 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
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Belching
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Capillary leak syndrome
Complete source fields
- event Groups
- deaths Num Affected
- 2
- deaths Num At Risk
- 2
- description
- Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma. Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles. For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV). Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated. Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
- id
- EG000
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 2
- serious Num At Risk
- 2
- title
- Dose Level 1: 400 mcg LMB-100
- frequency Threshold
- 0
- 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
- 2
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Activated partial thromboplastin time prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 5
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Allergic reaction
- 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
- 2
- num Events
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 6
- 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
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Back pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Belching
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Capillary leak syndrome
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 2
- num Events
- 2
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 2
- num Events
- 1
- term
- Lung infection
- 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
- 2
- num Events
- 1
- term
- Pericardial tamponade
- time Frame
- Date treatment consent signed to date off study, approximately 7 months.
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