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: 2021-10-15
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
UNKNOWN
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
6 months
Results posted on
2021-10-15
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=93 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 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: Up to 1 yearMeasured by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v. 5.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearA 95% binomial confidence interval for single proportions will be constructed for the percentage of patients that had at least one dose reduction, dose hold, or hospitalization within the first year of treatment.
Outcome measures
Outcome data not reported
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
Outcome data not reported
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
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearThe 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
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to the first of the following disease events: local/regional/distant recurrence, invasive contralateral breast disease, second primary or death due to any cause, assessed up to 5 yearsDistributions of progression free survival (PFS) times will be estimated using Kaplan-Meier methodology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsDistributions of overall survival (OS) times will be estimated using Kaplan-Meier methodology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearOTU 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
Outcome data not reported
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 yearEuropean 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. The median and range of this total score will be reported.
Outcome measures
Outcome data not reported
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 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Eye disorders
Eye disorders - Other, specify
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/92 • Number of events 8 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.1%
1/92 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
5.4%
5/92 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
General disorders
Chills
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
General disorders
Death NOS
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
6.5%
6/92 • Number of events 10 • 6 months
|
|
General disorders
Fever
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Flu like symptoms
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
2.2%
2/92 • Number of events 5 • 6 months
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Lung infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Upper respiratory infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Investigations
Creatinine increased
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Investigations
Neutrophil count decreased
|
10.9%
10/92 • Number of events 25 • 6 months
|
|
Investigations
Platelet count decreased
|
3.3%
3/92 • Number of events 7 • 6 months
|
|
Investigations
White blood cell decreased
|
8.7%
8/92 • Number of events 19 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
1.1%
1/92 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
3/92 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/92 • Number of events 4 • 6 months
|
|
Nervous system disorders
Stroke
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Confusion
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
5/92 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Vascular disorders
Hot flashes
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Vascular disorders
Hypertension
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
1.1%
1/92 • Number of events 1 • 6 months
|
Other 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
|
78.3%
72/92 • Number of events 549 • 6 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.3%
3/92 • Number of events 39 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
2/92 • Number of events 19 • 6 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.3%
3/92 • Number of events 3 • 6 months
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
3/92 • Number of events 13 • 6 months
|
|
Cardiac disorders
Heart failure
|
1.1%
1/92 • Number of events 20 • 6 months
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Cardiac disorders
Palpitations
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/92 • Number of events 4 • 6 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
2/92 • Number of events 5 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
2/92 • Number of events 5 • 6 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
3/92 • Number of events 44 • 6 months
|
|
Eye disorders
Blurred vision
|
6.5%
6/92 • Number of events 54 • 6 months
|
|
Eye disorders
Cataract
|
2.2%
2/92 • Number of events 17 • 6 months
|
|
Eye disorders
Dry eye
|
3.3%
3/92 • Number of events 5 • 6 months
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
3/92 • Number of events 8 • 6 months
|
|
Eye disorders
Eye pain
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Eye disorders
Watering eyes
|
2.2%
2/92 • Number of events 22 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/92 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
3/92 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
Bloating
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Cheilitis
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
18.5%
17/92 • Number of events 63 • 6 months
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
43.5%
40/92 • Number of events 214 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
10/92 • Number of events 53 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
7/92 • Number of events 39 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
4/92 • Number of events 16 • 6 months
|
|
Gastrointestinal disorders
Esophageal pain
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.2%
2/92 • Number of events 10 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.8%
9/92 • Number of events 35 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.3%
3/92 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Mucositis oral
|
32.6%
30/92 • Number of events 135 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
43.5%
40/92 • Number of events 153 • 6 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Rectal pain
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
14/92 • Number of events 25 • 6 months
|
|
General disorders
Chills
|
6.5%
6/92 • Number of events 8 • 6 months
|
|
General disorders
Edema face
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Edema limbs
|
8.7%
8/92 • Number of events 32 • 6 months
|
|
General disorders
Fatigue
|
84.8%
78/92 • Number of events 716 • 6 months
|
|
General disorders
Fever
|
4.3%
4/92 • Number of events 5 • 6 months
|
|
General disorders
Flu like symptoms
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Gait disturbance
|
2.2%
2/92 • Number of events 6 • 6 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Injection site reaction
|
3.3%
3/92 • Number of events 10 • 6 months
|
|
General disorders
Localized edema
|
1.1%
1/92 • Number of events 7 • 6 months
|
|
General disorders
Malaise
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/92 • Number of events 9 • 6 months
|
|
General disorders
Pain
|
20.7%
19/92 • Number of events 44 • 6 months
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Bone infection
|
1.1%
1/92 • Number of events 4 • 6 months
|
|
Infections and infestations
Bronchial infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Eye infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.3%
3/92 • Number of events 3 • 6 months
|
|
Infections and infestations
Lip infection
|
1.1%
1/92 • Number of events 7 • 6 months
|
|
Infections and infestations
Mucosal infection
|
1.1%
1/92 • Number of events 16 • 6 months
|
|
Infections and infestations
Otitis externa
|
1.1%
1/92 • Number of events 4 • 6 months
|
|
Infections and infestations
Otitis media
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Papulopustular rash
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Sinusitis
|
2.2%
2/92 • Number of events 4 • 6 months
|
|
Infections and infestations
Skin infection
|
2.2%
2/92 • Number of events 4 • 6 months
|
|
Infections and infestations
Tooth infection
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Infections and infestations
Upper respiratory infection
|
9.8%
9/92 • Number of events 10 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
7.6%
7/92 • Number of events 8 • 6 months
|
|
Infections and infestations
Wound infection
|
1.1%
1/92 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.4%
5/92 • Number of events 11 • 6 months
|
|
Injury, poisoning and procedural complications
Burn
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
6/92 • Number of events 6 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
4.3%
4/92 • Number of events 4 • 6 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
14/92 • Number of events 49 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
7.6%
7/92 • Number of events 29 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
12/92 • Number of events 45 • 6 months
|
|
Investigations
Blood bilirubin increased
|
1.1%
1/92 • Number of events 6 • 6 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/92 • Number of events 14 • 6 months
|
|
Investigations
CD4 lymphocytes decreased
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Investigations
Cholesterol high
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Investigations
Creatinine increased
|
21.7%
20/92 • Number of events 66 • 6 months
|
|
Investigations
Investigations - Other, specify
|
4.3%
4/92 • Number of events 15 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
28.3%
26/92 • Number of events 96 • 6 months
|
|
Investigations
Neutrophil count decreased
|
92.4%
85/92 • Number of events 885 • 6 months
|
|
Investigations
Platelet count decreased
|
66.3%
61/92 • Number of events 379 • 6 months
|
|
Investigations
Weight gain
|
1.1%
1/92 • Number of events 6 • 6 months
|
|
Investigations
Weight loss
|
4.3%
4/92 • Number of events 10 • 6 months
|
|
Investigations
White blood cell decreased
|
87.0%
80/92 • Number of events 897 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
30.4%
28/92 • Number of events 96 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
4/92 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.1%
1/92 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.3%
4/92 • Number of events 15 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.9%
22/92 • Number of events 104 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/92 • Number of events 5 • 6 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
2.2%
2/92 • Number of events 38 • 6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
2/92 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.1%
1/92 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
6/92 • Number of events 15 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.0%
11/92 • Number of events 25 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
6/92 • Number of events 15 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
2/92 • Number of events 8 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.6%
7/92 • Number of events 22 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Obesity
|
1.1%
1/92 • Number of events 17 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.8%
21/92 • Number of events 107 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/92 • Number of events 17 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.1%
24/92 • Number of events 129 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
6/92 • Number of events 31 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
2/92 • Number of events 6 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.7%
8/92 • Number of events 19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.1%
1/92 • Number of events 5 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.3%
3/92 • Number of events 11 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
12/92 • Number of events 43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
3/92 • Number of events 7 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.1%
1/92 • Number of events 17 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.4%
16/92 • Number of events 59 • 6 months
|
|
Nervous system disorders
Ataxia
|
1.1%
1/92 • Number of events 7 • 6 months
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
1/92 • Number of events 8 • 6 months
|
|
Nervous system disorders
Dizziness
|
7.6%
7/92 • Number of events 12 • 6 months
|
|
Nervous system disorders
Dysgeusia
|
8.7%
8/92 • Number of events 21 • 6 months
|
|
Nervous system disorders
Headache
|
9.8%
9/92 • Number of events 16 • 6 months
|
|
Nervous system disorders
Memory impairment
|
3.3%
3/92 • Number of events 15 • 6 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Nervous system disorders
Neuralgia
|
1.1%
1/92 • Number of events 15 • 6 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.2%
2/92 • Number of events 6 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
39.1%
36/92 • Number of events 315 • 6 months
|
|
Nervous system disorders
Tremor
|
3.3%
3/92 • Number of events 10 • 6 months
|
|
Nervous system disorders
Vasovagal reaction
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Agitation
|
1.1%
1/92 • Number of events 16 • 6 months
|
|
Psychiatric disorders
Anxiety
|
7.6%
7/92 • Number of events 20 • 6 months
|
|
Psychiatric disorders
Confusion
|
3.3%
3/92 • Number of events 6 • 6 months
|
|
Psychiatric disorders
Depression
|
10.9%
10/92 • Number of events 15 • 6 months
|
|
Psychiatric disorders
Insomnia
|
14.1%
13/92 • Number of events 72 • 6 months
|
|
Psychiatric disorders
Irritability
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Personality change
|
1.1%
1/92 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
3/92 • Number of events 27 • 6 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
1.1%
1/92 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
Glucosuria
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
4.3%
4/92 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
3/92 • Number of events 15 • 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
2/92 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
2/92 • Number of events 6 • 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.1%
1/92 • Number of events 8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
3/92 • Number of events 20 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
12/92 • Number of events 37 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.3%
15/92 • Number of events 73 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
2/92 • Number of events 8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.3%
27/92 • Number of events 102 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.2%
14/92 • Number of events 58 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
2/92 • Number of events 16 • 6 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.3%
3/92 • Number of events 8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.1%
1/92 • Number of events 18 • 6 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.1%
1/92 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
7/92 • Number of events 13 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.1%
1/92 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.3%
4/92 • Number of events 8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
2.2%
2/92 • Number of events 3 • 6 months
|
|
Vascular disorders
Hot flashes
|
18.5%
17/92 • Number of events 92 • 6 months
|
|
Vascular disorders
Hypertension
|
22.8%
21/92 • Number of events 138 • 6 months
|
|
Vascular disorders
Hypotension
|
3.3%
3/92 • Number of events 12 • 6 months
|
|
Vascular disorders
Lymphedema
|
7.6%
7/92 • Number of events 37 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
5.4%
5/92 • Number of events 13 • 6 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.2%
2/92 • Number of events 2 • 6 months
|
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