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NCT01376297 · ADVERSE EVENTS

Adverse events

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2014-11-17

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
The reporting period for AEs was the period starting from the time of informed consent signature until 21 (+2) days post study drug administration (Day 1 of last cycle).
Other-event reporting threshold
5%

Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as 'ongoing.'

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Netupitant and Palonosetron Plus Dexamethasone

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone

50 / 308265 / 308Not reported / Not reported
Aprepitant and Palonosetron Plus Dexamethasone

Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone

19 / 10495 / 104Not reported / Not reported

Group identifiers: EG000: Netupitant and Palonosetron Plus Dexamethasone · EG001: Aprepitant and Palonosetron Plus Dexamethasone

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
      0
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Agranulocytosis
  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
      3
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      104
    term
    Anaemia
  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
      6
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Febrile neutropenia
  4. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Pancytopenia
  6. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Cardiac arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Cardiopulmonary failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Long QT syndrome
  10. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Myocardial ischaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Ventricular extrasystoles
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Abdominal pain

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
      58
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      104
    term
    Anaemia
  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
      55
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      104
    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
      95
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      104
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      104
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      104
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      104
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      104
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      104
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      104
    term
    Stomatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      104
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      104
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      104
    term
    Pyrexia
Complete source fields
description
Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as 'ongoing.'
event Groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    EG000
    other Num Affected
    265
    other Num At Risk
    308
    serious Num Affected
    50
    serious Num At Risk
    308
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle. Aprepitant Palonosetron Dexamethasone
    id
    EG001
    other Num Affected
    95
    other Num At Risk
    104
    serious Num Affected
    19
    serious Num At Risk
    104
    title
    Aprepitant and Palonosetron Plus Dexamethasone
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
      58
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      104
    term
    Anaemia
  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
      55
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      104
    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
      95
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      104
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      104
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      104
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      104
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      104
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      104
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      104
    term
    Stomatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      104
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      104
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      104
    term
    Pyrexia
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
      0
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Agranulocytosis
  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
      3
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      104
    term
    Anaemia
  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
      6
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Febrile neutropenia
  4. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Pancytopenia
  6. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Cardiac arrest
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Cardiopulmonary failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Long QT syndrome
  10. 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
      308
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      104
    term
    Myocardial ischaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Ventricular extrasystoles
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      104
    term
    Abdominal pain
time Frame
The reporting period for AEs was the period starting from the time of informed consent signature until 21 (+2) days post study drug administration (Day 1 of last cycle).

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