NCT04430894 · 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
- The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Induction | 8 / 50 | 49 / 50 | 1 / 50 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Cholecystitis
- 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
- 50
- num Events
- 1
- term
- Pneumonitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Appendicitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Spinal Fracture
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Pulmonary Emboli
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Respiratory, thoracic and mediastinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- COVID-19
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Non-arteritic anterior ischemic optic neuropathy (NAION)
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Eye disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Cytokine release syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fever
- 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
- 50
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Right Hip Fracture
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Agitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 50
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 50
- term
- Alkaline phosphatase 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
- 50
- term
- Allergic Reaction
- 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
- 50
- term
- Allergic Rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 50
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Ankle fracture
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 50
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Arthralgia
Complete source fields
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 50
- description
- All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only). Patients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).
- id
- EG000
- other Num Affected
- 49
- other Num At Risk
- 50
- serious Num Affected
- 8
- serious Num At Risk
- 50
- title
- Induction
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Agitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 24
- num At Risk
- 50
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 50
- term
- Alkaline phosphatase 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
- 50
- term
- Allergic Reaction
- 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
- 50
- term
- Allergic Rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 50
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- term
- Ankle fracture
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 50
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 50
- term
- Arthralgia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Cholecystitis
- 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
- 50
- num Events
- 1
- term
- Pneumonitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Appendicitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Spinal Fracture
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Pulmonary Emboli
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Respiratory, thoracic and mediastinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- COVID-19
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Non-arteritic anterior ischemic optic neuropathy (NAION)
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Eye disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Cytokine release syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Fever
- 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
- 50
- num Events
- 1
- term
- Arthralgia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 50
- num Events
- 2
- term
- Acute Kidney Injury
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE (5.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 50
- num Events
- 1
- term
- Right Hip Fracture
- time Frame
- The AE data reported here extends from the start of study treatment through cycle 8 (224 days).
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