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NCT02685826 · ADVERSE EVENTS

Adverse events

A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2023-10-06

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
SAEs and Other AEs are assessed from first dose up to week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or DEX). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 88 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: High Risk, TNE

High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered - Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle - Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle - Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.

12 / 2524 / 259 / 25
Cohort B: >=65 Years Old, TNE

\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered - Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle - Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle - Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.

6 / 109 / 103 / 10
Cohort C: High Risk, Post-transplant

High risk, post-transplant NDMM participants were administered the following as maintenance therapy: Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.

4 / 2118 / 215 / 21

Group identifiers: EG000: Cohort A: High Risk, TNE · EG001: Cohort B: >=65 Years Old, TNE · EG002: Cohort C: High Risk, Post-transplant

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Inappropriate antidiuretic hormone secretion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    General physical health deterioration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cholecystitis acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Cytokine release syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Clostridium difficile infection

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Ear pruritus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      21
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Abdominal pain
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    25
    description
    High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered - Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle - Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle - Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    EG000
    other Num Affected
    24
    other Num At Risk
    25
    serious Num Affected
    12
    serious Num At Risk
    25
    title
    Cohort A: High Risk, TNE
  2. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered - Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle - Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle - Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Cohort B: >=65 Years Old, TNE
  3. deaths Num Affected
    5
    deaths Num At Risk
    21
    description
    High risk, post-transplant NDMM participants were administered the following as maintenance therapy: Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
    id
    EG002
    other Num Affected
    18
    other Num At Risk
    21
    serious Num Affected
    4
    serious Num At Risk
    21
    title
    Cohort C: High Risk, Post-transplant
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Ear pruritus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      21
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Inappropriate antidiuretic hormone secretion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    General physical health deterioration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cholecystitis acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Cytokine release syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Clostridium difficile infection
time Frame
SAEs and Other AEs are assessed from first dose up to week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or DEX). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 88 months).

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