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NCT01075321 · ADVERSE EVENTS

Adverse events

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma · Source last updated 2020-10-22

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
Not reported
Other-event reporting threshold
0%

Adverse Events (AEs) were assessed at the end of every 28 day cycle of treatment. Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow) and did not have protocol violation (i.e. Protocol Violation in participant flow). All-cause mortality is assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I: Dose Level -1

Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

3 / 76 / 76 / 7
Phase I: Dose Level 0

Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

7 / 99 / 96 / 9
Phase I: Dose Level 1

Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

5 / 77 / 77 / 8
Phase II: Dose Level 0

Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

14 / 3232 / 3218 / 32

Group identifiers: EG000: Phase I: Dose Level -1 · EG001: Phase I: Dose Level 0 · EG002: Phase I: Dose Level 1 · EG003: Phase II: Dose Level 0

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 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Duodenal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Mucositis oral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Obstruction gastric
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Cholecystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Appendicitis

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 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      32
      num Events
      27
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    External ear inflammation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      3
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      32
      num Events
      61
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Gastroesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      32
      num Events
      15
    term
    Mucositis oral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      32
      num Events
      39
    term
    Nausea
Complete source fields
description
Adverse Events (AEs) were assessed at the end of every 28 day cycle of treatment. Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow) and did not have protocol violation (i.e. Protocol Violation in participant flow). All-cause mortality is assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow).
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Phase I: Dose Level -1
  2. deaths Num Affected
    6
    deaths Num At Risk
    9
    description
    Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Phase I: Dose Level 0
  3. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Phase I: Dose Level 1
  4. deaths Num Affected
    18
    deaths Num At Risk
    32
    description
    Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG003
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    14
    serious Num At Risk
    32
    title
    Phase II: Dose Level 0
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      32
      num Events
      27
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    External ear inflammation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      3
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      9
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      32
      num Events
      61
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Gastroesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Gastrointestinal disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      32
      num Events
      15
    term
    Mucositis oral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      9
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      32
      num Events
      39
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Duodenal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Mucositis oral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Obstruction gastric
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      32
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Cholecystitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      32
      num Events
      1
    term
    Appendicitis

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Preserved source evidence · Not medical advice