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NCT03994705 · ADVERSE EVENTS

Adverse events

Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2025-05-15

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
Follow ups conducted on months 3,6,9,12.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level 1

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14

3 / 33 / 30 / 3
Dose Level 2

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14

2 / 42 / 41 / 4
Dose Level 3

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14

1 / 32 / 30 / 3
Dose Level 4A

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21

1 / 21 / 20 / 2
Dose Level 4B

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21

1 / 43 / 40 / 4
Dose Level 4C

Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21

0 / 42 / 41 / 4

Group identifiers: EG000: Dose Level 1 · EG001: Dose Level 2 · EG002: Dose Level 3 · EG003: Dose Level 4A · EG004: Dose Level 4B · EG005: Dose Level 4C

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Descartes-11
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Ileus
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unlikely related to Desartes-11
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Encephalopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Related to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Infusion reactions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Plasmacytoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dental Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Acute Kidney Injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Failure to thrive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Generalized weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pathologic fractures of right femur and left humerus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypotension

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Aspartate aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Kidney Disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dyspnea on exertion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Granulocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypoalbuminemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenic fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fever (Etiology Unknown)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Thrombocytopenia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Dose Level 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Dose Level 2
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Level 3
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Dose Level 4A
  5. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Dose Level 4B
  6. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose Level 4C
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Aspartate aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Kidney Disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dyspnea on exertion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Granulocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypoalbuminemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenic fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Fever (Etiology Unknown)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Descartes-11
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Ileus
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unlikely related to Desartes-11
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Encephalopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Related to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Infusion reactions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Plasmacytoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Dental Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Acute Kidney Injury
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Failure to thrive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Generalized weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pathologic fractures of right femur and left humerus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated to Desartes-11
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE VERSION 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hypotension
time Frame
Follow ups conducted on months 3,6,9,12.

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Preserved source evidence · Not medical advice