NCT01772420 · 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
- Through study completion, up to 2 years
- Other-event reporting threshold
- 0%
Adverse events categorized based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm A (Platelets > 50,000 k/uL) LEN Initiation | 8 / 16 | 15 / 16 | 1 / 16 |
| Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination | 5 / 15 | 9 / 15 | 2 / 15 |
| Arm C (Platelets < 50,000 k/uL) ELT Monotherapy | 0 / 21 | 4 / 21 | 0 / 21 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Unspecified)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 16
- num Events
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 15
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Severe thrombocytopenia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Thrombocytopenia (severe)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Pneumonia
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Lung Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Gall Bladder Cancer
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Hyperbilirubinemia from development of bone marrow fibrosis
- organ System
- Investigations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 15
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Blood Bilirubin Increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- AST/ALT elevation, reversible increase in peripheral blasts
- organ System
- Investigations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Acute Cholecystitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right Arm Hematoma
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Hematoma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Upper Gastrointestinal Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 16
- num Events
- 4
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Unspecified)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 15
- num Events
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Rash
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Arthralgia
Complete source fields
- description
- Adverse events categorized based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 16
- description
- Patients with baseline platelet counts \>50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts \> 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count \>50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were \>50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
- id
- EG000
- other Num Affected
- 15
- other Num At Risk
- 16
- serious Num Affected
- 8
- serious Num At Risk
- 16
- title
- Arm A (Platelets > 50,000 k/uL) LEN Initiation
- deaths Num Affected
- 2
- deaths Num At Risk
- 15
- description
- Patients with baseline platelet counts \<50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count \>50,000 k/uL was achieved. Once a platelet count\>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
- id
- EG001
- other Num Affected
- 9
- other Num At Risk
- 15
- serious Num Affected
- 5
- serious Num At Risk
- 15
- title
- Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination
- deaths Num Affected
- 0
- deaths Num At Risk
- 21
- description
- Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies
- id
- EG002
- other Num Affected
- 4
- other Num At Risk
- 21
- serious Num Affected
- 0
- serious Num At Risk
- 21
- title
- Arm C (Platelets < 50,000 k/uL) ELT Monotherapy
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Hyperbilirubinemia from development of bone marrow fibrosis
- organ System
- Investigations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 15
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Blood Bilirubin Increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- AST/ALT elevation, reversible increase in peripheral blasts
- organ System
- Investigations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Acute Cholecystitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right Arm Hematoma
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Hematoma
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Upper Gastrointestinal Hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 16
- num Events
- 4
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Unspecified)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 15
- num Events
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Rash
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Arthralgia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Unspecified)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 16
- num Events
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 15
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Severe thrombocytopenia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 16
- num Events
- 2
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Thrombocytopenia (severe)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Pneumonia
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 16
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 15
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Lung Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (Version 5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 16
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 15
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Gall Bladder Cancer
- time Frame
- Through study completion, up to 2 years
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