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NCT00560391 · ADVERSE EVENTS

Adverse events

Dasatinib in Combination With Revlimid (and Dexamethasone) · Source last updated 2016-08-04

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

2 / 33 / 3Not reported / Not reported
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

5 / 66 / 6Not reported / Not reported
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.

9 / 1717 / 17Not reported / Not reported
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

0 / 60 / 6Not reported / Not reported
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

0 / 30 / 3Not reported / Not reported

Group identifiers: EG000: Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg · EG001: Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg · EG002: Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg · EG003: Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg · EG004: Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Rash
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Chronic obstructive pulmonary disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Pleural effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Arrhythmia

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
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Cyst
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Depression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Fall
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Gastrooesophageal reflux disease
Complete source fields
event Groups
  1. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  2. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  3. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  4. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
  5. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Cyst
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Depression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Fall
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Colitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Rash
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Chronic obstructive pulmonary disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Pleural effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    term
    Arrhythmia

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Preserved source evidence · Not medical advice