Trial Outcomes & Findings for Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer (NCT NCT03633331)
NCT ID: NCT03633331
Last Updated: 2026-04-29
Results Overview
Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
6 months
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=93 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Continuous
|
74 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: patients meeting the eligibility criteria who have not withdrawn before treatment and have adverse event data available are considered evaluable for the primary endpoint.
Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=90 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Incidence of Adverse Events
|
0.756 proportion of patients
Interval 0.654 to 0.84
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All treated patients.
Measured by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v. 5.0. Reported in this section is the percentage of patients that experienced a grade 3 or higher toxicity.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Commonality of Grade 3+ Drug Toxicities
|
62.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearDosing interruption and/or dose reductions are recommended based on individual safety and tolerability. Palbociclib cycle length will remain 28 days (± 2 days) (despite a delay in initiating a new cycle of palbociclib); endocrine therapy may continue to be administered per the preplanned schedule. * Dose holds/reductions of letrozole or fulvestrant will occur per the package insert and the treating investigator's discretion. * Dose escalation will not be permitted in this study. * Palbociclib doses missed for toxicity will not be made up. * The initiation of a new cycle may be delayed for up to 7 days
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Renal and Urinary Disorders
|
0 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Skin and Subcutaneous Tissue Disorders
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Surgical and Medical Procedures
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Other, not per protocol
|
16 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Infections and Infestations
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Blood and lymphatic system disorders
|
30 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Cardiac Disorders
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Gastrointestinal Disorders
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : General Disorders and administration site conditions
|
3 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Immune System Disorders
|
2 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Blood and lymphatic system disorders
|
24 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Cardiac Disorders
|
0 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Gastrointestinal Disorders
|
0 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : General Disorders and administration site conditions
|
2 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Immune System Disorders
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Investigations
|
10 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Renal and Urinary Disorders
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Respiratory, Thoracic, and Mediastinal Disorders
|
3 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Skin and Subcutaneous Tissue Disorders
|
0 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Other, not per protocol
|
38 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Infections and Infestations
|
2 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Surgical and Medical Procedures
|
1 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Reduced : Respiratory, Thoracic, and Mediastinal Disorders
|
0 participants with event
|
|
Dose Reduction, Dose Hold, and Hospitalization Reasons
Reason Dose Held : Investigations
|
18 participants with event
|
SECONDARY outcome
Timeframe: Up to 5 yearsDistributions time to treatment failure will be estimated using Kaplan-Meier methodology. Treatment failure is defined as a severe adverse event, disease progression or patient refusal to continue assigned treatment. Any reason that treatment is discontinued to time to treatment failure and not censor patients will be included. The reason for treatment discontinuation will be captured.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression)
|
450 Days
Interval 344.0 to 607.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksPatients to be included in the analysis cohort will be those patients who have taken one or more doses of the study treatment. Those patients will be considered adherent to study treatment. For each of the first 3 cycles, an estimate of the proportion of patients who meet the criteria for adherence and its corresponding 95% confidence interval will be determined.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Palbociclib Adherence Rate
Cycle 1
|
100 percentage of participants adherent
|
|
Palbociclib Adherence Rate
Cycle 2
|
94.3 percentage of participants adherent
|
|
Palbociclib Adherence Rate
Cycle 3
|
97.6 percentage of participants adherent
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: All treated patients with measurable disease.
The response rate is defined as the proportion of patients whose disease status met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 8 weeks apart. A 95% binomial confidence interval for the response rate will be constructed.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=47 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
|
55 percentage of patients that responded
Interval 40.0 to 70.0
|
SECONDARY outcome
Timeframe: up to 5 yearsDistributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology. The PFS time is calculated as the time between a patients start of treatment and their disease progression or death.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Progression Free Survival (PFS)
|
895 Days
Interval 757.0 to
Not enough events occurred to reach upper confidence interval
|
SECONDARY outcome
Timeframe: Up to 5 yearsDistributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology. OS time is calculated as the time between the date a patient started treatment and their death.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=91 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Survival (OS)
|
1084 Days
Interval 1084.0 to
Not enough events to calculate the upper confidence interval
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: All treated patients that completed both the onstudy and end of treatment assessments.
OTU is a novel composite endpoint developed by investigators of the FOCUS2 trial to assess the outcome of palliative chemotherapy. The patient will be given either an overall score of "good", "intermediate", or "poor". A 95% binomial confidence interval will be constructed for the percentage of patients that scored "good" on the OTU.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=60 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Treatment Utility (OTU) Results
Intermediate Utility
|
28 Participants
|
|
Overall Treatment Utility (OTU) Results
Good Utility
|
6 Participants
|
|
Overall Treatment Utility (OTU) Results
Poor Utility
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearWill examine variables associated with skeletal muscle loss during treatment and whether skeletal muscle loss during treatment is associated with the presence of grade 3-5 toxicity and adverse events. Sarcopenia will be treated as a binary variable using the Skeletal Muscle Index (SMI) (SMI \< 41 cm\^2/m\^2 vs. SMI \> 41 cm\^2/m\^2) and differences in grades chemotherapy toxicity and adverse events will be analyzed using two group t-tests and fisher's exact test. The number of patients with and without sarcopenia grouped by patients with or without grade 3+ Adverse Events (AE's) will be also be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: All treated patients that completed the EQ5D-3L questionnaire
European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) is comprised of 5 dimensions. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, no problems, some problems, extreme problems. The EQ-5D-3L can be converted to a single summary index, 0-1, where higher scores mean better health. The median and range of this total score will be reported.
Outcome measures
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=85 Participants
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L)
|
0.8 score on a scale
Interval 0.3 to 1.0
|
Adverse Events
Treatment (Palbociclib, Letrozole or Fulvestrant)
Serious events: 35 serious events
Other events: 92 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=92 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
6/92 • Number of events 19 • Adverse Events for 1 year and Mortality for 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.1%
1/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Nausea
|
5.4%
5/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Chills
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Death NOS
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Fatigue
|
6.5%
6/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Fever
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Flu like symptoms
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.2%
2/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Lung infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Upper respiratory infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Creatinine increased
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Neutrophil count decreased
|
10.9%
10/92 • Number of events 25 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Platelet count decreased
|
3.3%
3/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
White blood cell decreased
|
8.7%
8/92 • Number of events 19 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.1%
1/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
3/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Stroke
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Confusion
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
5/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Hot flashes
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Hypertension
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Thromboembolic event
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
Other adverse events
| Measure |
Treatment (Palbociclib, Letrozole or Fulvestrant)
n=92 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
2/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.7%
8/92 • Number of events 19 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.1%
1/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.3%
3/92 • Number of events 11 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
12/92 • Number of events 43 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
3/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.1%
1/92 • Number of events 17 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.4%
16/92 • Number of events 59 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Ataxia
|
1.1%
1/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
1/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Dizziness
|
7.6%
7/92 • Number of events 12 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Dysgeusia
|
8.7%
8/92 • Number of events 21 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Headache
|
9.8%
9/92 • Number of events 16 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Memory impairment
|
3.3%
3/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.2%
2/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
39.1%
36/92 • Number of events 315 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Tremor
|
3.3%
3/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
Nervous system disorders
Vasovagal reaction
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Agitation
|
1.1%
1/92 • Number of events 16 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Anxiety
|
7.6%
7/92 • Number of events 20 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Confusion
|
3.3%
3/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Depression
|
10.9%
10/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Insomnia
|
14.1%
13/92 • Number of events 72 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Irritability
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Psychiatric disorders
Personality change
|
1.1%
1/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
3/92 • Number of events 27 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
1.1%
1/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Glucosuria
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Hematuria
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
4.3%
4/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
3/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
2/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.1%
1/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
3/92 • Number of events 20 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
12/92 • Number of events 37 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.3%
15/92 • Number of events 73 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
2/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.3%
27/92 • Number of events 102 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.2%
14/92 • Number of events 58 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
2/92 • Number of events 16 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.3%
3/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.1%
1/92 • Number of events 18 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
7/92 • Number of events 13 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.3%
4/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Hot flashes
|
18.5%
17/92 • Number of events 92 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Hypertension
|
22.8%
21/92 • Number of events 138 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Hypotension
|
3.3%
3/92 • Number of events 12 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Lymphedema
|
7.6%
7/92 • Number of events 37 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Thromboembolic event
|
5.4%
5/92 • Number of events 13 • Adverse Events for 1 year and Mortality for 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Cheilitis
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Constipation
|
18.5%
17/92 • Number of events 63 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
43.5%
40/92 • Number of events 214 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
10/92 • Number of events 53 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
7/92 • Number of events 39 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
4/92 • Number of events 16 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Esophageal pain
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.2%
2/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.8%
9/92 • Number of events 35 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.3%
3/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
32.6%
30/92 • Number of events 135 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Nausea
|
43.5%
40/92 • Number of events 153 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Rectal pain
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
14/92 • Number of events 25 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Chills
|
6.5%
6/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Edema face
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Edema limbs
|
8.7%
8/92 • Number of events 32 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Fatigue
|
84.8%
78/92 • Number of events 716 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Fever
|
4.3%
4/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Flu like symptoms
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Gait disturbance
|
2.2%
2/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Injection site reaction
|
3.3%
3/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Localized edema
|
1.1%
1/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Malaise
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/92 • Number of events 9 • Adverse Events for 1 year and Mortality for 5 years
|
|
General disorders
Pain
|
20.7%
19/92 • Number of events 44 • Adverse Events for 1 year and Mortality for 5 years
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Bone infection
|
1.1%
1/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Bronchial infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Eye infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.3%
3/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Lip infection
|
1.1%
1/92 • Number of events 7 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Mucosal infection
|
1.1%
1/92 • Number of events 16 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Otitis externa
|
1.1%
1/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Otitis media
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Papulopustular rash
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Sinusitis
|
2.2%
2/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Skin infection
|
2.2%
2/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Tooth infection
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Upper respiratory infection
|
9.8%
9/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Urinary tract infection
|
7.6%
7/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Infections and infestations
Wound infection
|
1.1%
1/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
5.4%
5/92 • Number of events 11 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Burn
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
6/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
4.3%
4/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
14/92 • Number of events 49 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Alkaline phosphatase increased
|
7.6%
7/92 • Number of events 29 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
12/92 • Number of events 45 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/92 • Number of events 14 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Cholesterol high
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Creatinine increased
|
21.7%
20/92 • Number of events 66 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Investigations - Other, specify
|
4.3%
4/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Lymphocyte count decreased
|
28.3%
26/92 • Number of events 96 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Neutrophil count decreased
|
92.4%
85/92 • Number of events 885 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Platelet count decreased
|
66.3%
61/92 • Number of events 379 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Weight gain
|
1.1%
1/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
Weight loss
|
4.3%
4/92 • Number of events 10 • Adverse Events for 1 year and Mortality for 5 years
|
|
Investigations
White blood cell decreased
|
87.0%
80/92 • Number of events 897 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.4%
28/92 • Number of events 96 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
4/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.1%
1/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.3%
4/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.9%
22/92 • Number of events 104 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
2.2%
2/92 • Number of events 38 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
2/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.1%
1/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
6/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.0%
11/92 • Number of events 25 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
6/92 • Number of events 15 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
2/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.6%
7/92 • Number of events 22 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
1.1%
1/92 • Number of events 17 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.8%
21/92 • Number of events 107 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/92 • Number of events 17 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.1%
24/92 • Number of events 129 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
6/92 • Number of events 31 • Adverse Events for 1 year and Mortality for 5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Eye pain
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Watering eyes
|
2.2%
2/92 • Number of events 22 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/92 • Number of events 6 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
3/92 • Number of events 9 • Adverse Events for 1 year and Mortality for 5 years
|
|
Gastrointestinal disorders
Bloating
|
2.2%
2/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
78.3%
72/92 • Number of events 549 • Adverse Events for 1 year and Mortality for 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.3%
3/92 • Number of events 39 • Adverse Events for 1 year and Mortality for 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
2/92 • Number of events 19 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.3%
3/92 • Number of events 3 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
3/92 • Number of events 13 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Heart failure
|
1.1%
1/92 • Number of events 20 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Palpitations
|
1.1%
1/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
2/92 • Number of events 2 • Adverse Events for 1 year and Mortality for 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/92 • Number of events 4 • Adverse Events for 1 year and Mortality for 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
2/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
2/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.1%
1/92 • Number of events 1 • Adverse Events for 1 year and Mortality for 5 years
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
3/92 • Number of events 44 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Blurred vision
|
6.5%
6/92 • Number of events 54 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Cataract
|
2.2%
2/92 • Number of events 17 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Dry eye
|
3.3%
3/92 • Number of events 5 • Adverse Events for 1 year and Mortality for 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
3/92 • Number of events 8 • Adverse Events for 1 year and Mortality for 5 years
|
Additional Information
Mina S. Sedrak MD, MS
City of Hope Comprehensive Cancer Center
Phone: 626-218-4173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place