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NCT01339260 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2014-11-26

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
Period from time of informed consent signature until 21 days post study drugs (Day 1 of the last cycle). Upon Investigator's judgment, all non resolved, non serious Adverse Events (AEs) beyond this date could have been followed for an additional 14 days
Other-event reporting threshold
5%

AEs are presented separately for cycle 1 and for multi-cycle extension (i.e. without Cycle 1), consistent with Analysis Plan and Clinical Study Report

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Netupitant and Palonosetron+Dexamethasone-cycle 1

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle

13 / 725551 / 725Not reported / Not reported
Palonosetron+Dexamethasone-cycle 1

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle

12 / 725507 / 725Not reported / Not reported
Netupitant and Palonosetron+Dexamethasone-multicycle Extension

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle

23 / 635533 / 635Not reported / Not reported
Palonosetron+Dexamethasone-multicycle Extension

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle

15 / 651527 / 651Not reported / Not reported

Group identifiers: EG000: Netupitant and Palonosetron+Dexamethasone-cycle 1 · EG001: Palonosetron+Dexamethasone-cycle 1 · EG002: Netupitant and Palonosetron+Dexamethasone-multicycle Extension · EG003: Palonosetron+Dexamethasone-multicycle Extension

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      651
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      651
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Cytotoxic cardiomyopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Hypokalaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Metrorrhagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Central venous catheterisation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Anaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Thrombocytopenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Vomiting

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      141
      num At Risk
      651
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      182
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      238
      num At Risk
      651
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      69
      num At Risk
      651
    term
    Asthenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      651
    term
    Fatigue
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      651
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      253
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      253
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      152
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      151
      num At Risk
      651
    term
    Alopecia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      651
    term
    Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      651
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      651
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      651
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      651
    term
    Decreased appetite
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      651
    term
    Hyperglycaemia
Complete source fields
description
AEs are presented separately for cycle 1 and for multi-cycle extension (i.e. without Cycle 1), consistent with Analysis Plan and Clinical Study Report
event Groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
    id
    EG000
    other Num Affected
    551
    other Num At Risk
    725
    serious Num Affected
    13
    serious Num At Risk
    725
    title
    Netupitant and Palonosetron+Dexamethasone-cycle 1
  2. description
    Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
    id
    EG001
    other Num Affected
    507
    other Num At Risk
    725
    serious Num Affected
    12
    serious Num At Risk
    725
    title
    Palonosetron+Dexamethasone-cycle 1
  3. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
    id
    EG002
    other Num Affected
    533
    other Num At Risk
    635
    serious Num Affected
    23
    serious Num At Risk
    635
    title
    Netupitant and Palonosetron+Dexamethasone-multicycle Extension
  4. description
    Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
    id
    EG003
    other Num Affected
    527
    other Num At Risk
    651
    serious Num Affected
    15
    serious Num At Risk
    651
    title
    Palonosetron+Dexamethasone-multicycle Extension
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      141
      num At Risk
      651
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      173
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      182
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      238
      num At Risk
      651
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      70
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      69
      num At Risk
      651
    term
    Asthenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      651
    term
    Fatigue
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      651
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      253
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      253
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      152
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      151
      num At Risk
      651
    term
    Alopecia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      651
    term
    Anaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      651
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      651
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      651
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      42
      num At Risk
      651
    term
    Decreased appetite
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      651
    term
    Hyperglycaemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      651
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      651
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Cytotoxic cardiomyopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Hypokalaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Metrorrhagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Central venous catheterisation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Anaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      651
    term
    Thrombocytopenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      725
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      725
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      635
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      651
    term
    Vomiting
time Frame
Period from time of informed consent signature until 21 days post study drugs (Day 1 of the last cycle). Upon Investigator's judgment, all non resolved, non serious Adverse Events (AEs) beyond this date could have been followed for an additional 14 days

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Preserved source evidence · Not medical advice