Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02557035 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus 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
7 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
I.V. Palonosetron Infusion Plus Dexamethasone

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

15 / 22514 / 2251 / 225
I.V. Palonosetron Bolus Plus Dexamethasone

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

12 / 21522 / 2150 / 215

Group identifiers: EG000: I.V. Palonosetron Infusion Plus Dexamethasone · EG001: I.V. Palonosetron Bolus 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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      215
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Mesenteric vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Asthenia

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
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      215
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      215
    term
    Asthenia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    225
    description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    225
    serious Num Affected
    15
    serious Num At Risk
    225
    title
    I.V. Palonosetron Infusion Plus Dexamethasone
  2. deaths Num Affected
    0
    deaths Num At Risk
    215
    description
    Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Palonosetron Dexamethasone
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    215
    serious Num Affected
    12
    serious Num At Risk
    215
    title
    I.V. Palonosetron Bolus Plus Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      215
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      215
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      215
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Mesenteric vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      225
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Asthenia
time Frame
7 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice