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NCT03673124 · ADVERSE EVENTS

Adverse events

Ribociclib and Letrozole Treatment in Ovarian Cancer · Source last updated 2025-12-23

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
The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months.
Other-event reporting threshold
0%

Eligible participants who received any amount of protocol therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ribociclib and Letrozole

Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle plus Letrozole 2.5 mg administered orally daily for 28 days.

29 / 4949 / 4922 / 49

Group identifiers: EG000: Ribociclib and Letrozole

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
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Sinus Tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pericarditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiac Arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Eye Disorders - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pancreatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    term
    Small Intestinal Obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Gastrointestinal Disorders - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    term
    Abdominal Pain

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
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      49
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Sinus Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Sinus Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Cardiac Disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Chest Pain - Cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiac Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Ear And Labyrinth Disorders - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Vertigo
Complete source fields
description
Eligible participants who received any amount of protocol therapy.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    49
    description
    Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle plus Letrozole 2.5 mg administered orally daily for 28 days.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    29
    serious Num At Risk
    49
    title
    Ribociclib and Letrozole
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      49
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Sinus Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    term
    Sinus Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Cardiac Disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Chest Pain - Cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiac Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Ear And Labyrinth Disorders - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Vertigo
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Sinus Tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pericarditis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Cardiac Arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Eye Disorders - Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Pancreatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    term
    Small Intestinal Obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Gastrointestinal Disorders - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    term
    Abdominal Pain
time Frame
The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months.

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