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NCT01363479 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2021-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
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
Oral Palonosteron Plus Dexamethasone

Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosetron Dexamethasone

36 / 370168 / 370Not reported / Not reported
I.V. Palonosetron Plus Dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron Dexamethasone

36 / 369171 / 369Not reported / Not reported

Group identifiers: EG000: Oral Palonosteron Plus Dexamethasone · EG001: I.V. 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
      1
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      369
    term
    Anemia
  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
      370
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      369
    term
    Febrile Neutropenia
  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
      1
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Leucopenia
  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
      5
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      369
    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
      370
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      369
    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
      2
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      369
    term
    Thrombocytopenia
  7. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Acute Myocardial Infarction
  8. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Angina unstable
  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
      370
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      369
    term
    Arteriosclerosis coronary artery
  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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Arteriospasm coronary
  11. 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
      370
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      369
    term
    Cardiac failure acute
  12. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Cardiopulmonary failure

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
      21
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      369
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      369
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      369
    term
    Asthenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      369
    term
    Decreased appetite
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      369
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      369
    term
    Investigations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      369
    term
    Respiratory, thoracic and mediastinal disorder
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 palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosetron Dexamethasone
    id
    EG000
    other Num Affected
    168
    other Num At Risk
    370
    serious Num Affected
    36
    serious Num At Risk
    370
    title
    Oral Palonosteron Plus Dexamethasone
  2. description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron Dexamethasone
    id
    EG001
    other Num Affected
    171
    other Num At Risk
    369
    serious Num Affected
    36
    serious Num At Risk
    369
    title
    I.V. 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
      21
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      369
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      369
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      369
    term
    Asthenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      369
    term
    Decreased appetite
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      369
    term
    Headache
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      369
    term
    Investigations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      369
    term
    Respiratory, thoracic and mediastinal disorder
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
      1
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      369
    term
    Anemia
  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
      370
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      369
    term
    Febrile Neutropenia
  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
      1
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Leucopenia
  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
      5
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      369
    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
      370
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      369
    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
      2
      num At Risk
      370
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      369
    term
    Thrombocytopenia
  7. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Acute Myocardial Infarction
  8. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Angina unstable
  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
      370
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      369
    term
    Arteriosclerosis coronary artery
  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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Arteriospasm coronary
  11. 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
      370
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      369
    term
    Cardiac failure acute
  12. 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
      370
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      369
    term
    Cardiopulmonary failure
time Frame
Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.

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