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NCT02517021 · ADVERSE EVENTS

Adverse events

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting · Source last updated 2018-06-20

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
10 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pro-netupitant/Palonosetron Plus Dexamethasone

Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone

41 / 203169 / 20310 / 203
Netupitant/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/Palonosetron Dexamethasone

43 / 201174 / 20114 / 201

Group identifiers: EG000: Pro-netupitant/Palonosetron Plus Dexamethasone · EG001: Netupitant/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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      201
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      201
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      201
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Extrasystoles
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Gastric haemorrhage

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 (18.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      201
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      201
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      201
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      201
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      201
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      201
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      201
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      201
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      201
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      201
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      201
    term
    Decreased appetite
Complete source fields
event Groups
  1. deaths Num Affected
    10
    deaths Num At Risk
    203
    description
    Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Pro-netupitant/Palonosetron Dexamethasone
    id
    EG000
    other Num Affected
    169
    other Num At Risk
    203
    serious Num Affected
    41
    serious Num At Risk
    203
    title
    Pro-netupitant/Palonosetron Plus Dexamethasone
  2. deaths Num Affected
    14
    deaths Num At Risk
    201
    description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle Netupitant/Palonosetron Dexamethasone
    id
    EG001
    other Num Affected
    174
    other Num At Risk
    201
    serious Num Affected
    43
    serious Num At Risk
    201
    title
    Netupitant/Palonosetron Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      201
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      201
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      201
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      201
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      201
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      201
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      201
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      201
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      201
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      201
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      201
    term
    Decreased appetite
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      201
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      201
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      201
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Extrasystoles
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      201
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      203
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      201
    term
    Gastric haemorrhage
time Frame
10 months

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