Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02624388 · ADVERSE EVENTS

Adverse events

Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) · Source last updated 2024-05-06

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
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

1 / 22 / 20 / 2
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles

Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

1 / 22 / 21 / 2
Arm A: Genistein Followed by Placebo - PLACEBO Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

1 / 20 / 20 / 2
Arm B: Placebo Followed by Genistein - PLACEBO Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

1 / 20 / 20 / 2

Group identifiers: EG000: Arm A: Genistein Followed by Placebo - GENISTEIN Cycles · EG001: Arm B: Placebo Followed by Genistein - GENISTEIN Cycles · EG002: Arm A: Genistein Followed by Placebo - PLACEBO Cycles · EG003: Arm B: Placebo Followed by Genistein - PLACEBO Cycles

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
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    febrile neutropenia

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
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Anal mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      4
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      9
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Platelet count decreased
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
  2. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
  3. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Arm A: Genistein Followed by Placebo - PLACEBO Cycles
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Arm B: Placebo Followed by Genistein - PLACEBO Cycles
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Anal mucositis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      4
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      9
    3. group Id
      EG002
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      2
    term
    Platelet count decreased
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
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    febrile neutropenia
time Frame
All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice