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NCT02872103 · ADVERSE EVENTS

Adverse events

Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2021-05-05

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
AEs and SAEs were collected from the time of randomization until 28 days after completion of the trial (a total of 16 weeks) or 28 days after premature withdrawal of a subject from the trial.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cycle 1 F-627

F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.

4 / 8317 / 830 / 83
Cycle 1 Placebo

Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1

10 / 395 / 390 / 39
All 4 Cycles F-627

F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.

4 / 8326 / 830 / 83
Cycle 1 Placebo and Cycle 2-4 F-627

Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.

11 / 399 / 390 / 39

Group identifiers: EG000: Cycle 1 F-627 · EG001: Cycle 1 Placebo · EG002: All 4 Cycles F-627 · EG003: Cycle 1 Placebo and Cycle 2-4 F-627

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
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      39
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
    term
    Tumor hemorrhage

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      39
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Bone pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
    term
    Fatigue
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    83
    description
    F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    83
    serious Num Affected
    4
    serious Num At Risk
    83
    title
    Cycle 1 F-627
  2. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle 1
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    39
    serious Num Affected
    10
    serious Num At Risk
    39
    title
    Cycle 1 Placebo
  3. deaths Num Affected
    0
    deaths Num At Risk
    83
    description
    F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
    id
    EG002
    other Num Affected
    26
    other Num At Risk
    83
    serious Num Affected
    4
    serious Num At Risk
    83
    title
    All 4 Cycles F-627
  4. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    39
    serious Num Affected
    11
    serious Num At Risk
    39
    title
    Cycle 1 Placebo and Cycle 2-4 F-627
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      39
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
    term
    Stomatitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Bone pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      39
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      83
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
    term
    Tumor hemorrhage
time Frame
AEs and SAEs were collected from the time of randomization until 28 days after completion of the trial (a total of 16 weeks) or 28 days after premature withdrawal of a subject from the trial.

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Preserved source evidence · Not medical advice