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NCT03673124 · OUTCOME

Incidence of Adverse Events (Grade 3 or Higher)

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
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.

What was measured

Number of participants who experienced at least one adverse event of grade 3 or higher. Adverse events were graded and categorized using CTCAE v5.0.

Analysis population: Eligible participants who received any amount of protocol therapy.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ribociclib and Letrozole49

Reported measurements

Blood and lymphatic system disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole2Not reportedNot reportedNot reportedNot reported
Cardiac disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole1Not reportedNot reportedNot reportedNot reported
Eye disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole1Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole15Not reportedNot reportedNot reportedNot reported
General disorders and administration site conditions
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole2Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole6Not reportedNot reportedNot reportedNot reported
Injury, poisoning and procedural complications
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole2Not reportedNot reportedNot reportedNot reported
Investigations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole25Not reportedNot reportedNot reportedNot reported
Metabolism and nutrition disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole6Not reportedNot reportedNot reportedNot reported
Musculoskeletal and connective tissue disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole3Not reportedNot reportedNot reportedNot reported
Nervous system disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole2Not reportedNot reportedNot reportedNot reported
Psychiatric disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole1Not reportedNot reportedNot reportedNot reported
Renal and urinary disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole3Not reportedNot reportedNot reportedNot reported
Respiratory, thoracic and mediastinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole3Not reportedNot reportedNot reportedNot reported
Skin and subcutaneous tissue disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole1Not reportedNot reportedNot reportedNot reported
Vascular disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib and Letrozole5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Blood and lymphatic system disorders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cardiac disorders
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Eye disorders
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Gastrointestinal disorders
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    General disorders and administration site conditions
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Infections and infestations
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Injury, poisoning and procedural complications
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Investigations
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Metabolism and nutrition disorders
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Musculoskeletal and connective tissue disorders
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Nervous system disorders
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Psychiatric disorders
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
Number of participants who experienced at least one adverse event of grade 3 or higher. Adverse events were graded and categorized using CTCAE v5.0.
groups
  1. 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
    OG000
    title
    Ribociclib and Letrozole
param Type
NUMBER
population Description
Eligible participants who received any amount of protocol therapy.
reporting Status
POSTED
time Frame
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.
title
Incidence of Adverse Events (Grade 3 or Higher)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice