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NCT01459653 · ADVERSE EVENTS

Adverse events

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor · Source last updated 2016-01-11

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
Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
Other-event reporting threshold
0.5%

The occurrence of adverse drug reactions (ADRs) not including not-related (S)AEs was sought by non-directive questioning of the patient at each visit during the study. Only Adverse events with a suspected relationship to EP2006 were collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
EP2006

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.

4 / 149636 / 1496Not reported / Not reported

Group identifiers: EG000: EP2006

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
    Immune system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Drug hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Vulvul abscess
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Loss of consciousness

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      1496
      num Events
      33
    term
    Bone pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1496
      num Events
      21
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      1496
      num Events
      11
    term
    Myalgia
Complete source fields
description
The occurrence of adverse drug reactions (ADRs) not including not-related (S)AEs was sought by non-directive questioning of the patient at each visit during the study. Only Adverse events with a suspected relationship to EP2006 were collected.
event Groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    1496
    serious Num Affected
    4
    serious Num At Risk
    1496
    title
    EP2006
frequency Threshold
0.5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      1496
      num Events
      33
    term
    Bone pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1496
      num Events
      21
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      1496
      num Events
      11
    term
    Myalgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Drug hypersensitivity
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Vulvul abscess
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1496
      num Events
      1
    term
    Loss of consciousness
time Frame
Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

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Preserved source evidence · Not medical advice