Trial Outcomes & Findings for Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy (NCT NCT00216060)
NCT ID: NCT00216060
Last Updated: 2016-05-26
Results Overview
Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
36 months
Results posted on
2016-05-26
Participant Flow
Target patients were men with castrate resistant prostate cancer for whom androgen-deprivation therapy was planned. Patients were enrolled at multiple outpatient oncology clinics and urological practices in the United States and Canada. Recruitment period was December 2003 and August 2005.
1:1 stratification was based on patient's age, performance status and severity of metastatic disease. Initial clinical evaluation was performed during the 2-week screening period. Both arms received at least 500 mg/day oral calcium carbonate and 400 IU of vitamin D.
Participant milestones
| Measure |
Risedronate
Daily oral risedronate combined with androgen deprivation
|
Placebo
daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Baseline characteristics by cohort
| Measure |
Risedronate
n=32 Participants
Daily oral risedronate combined with androgen deprivation
|
Placebo
n=31 Participants
daily oral placebo combined with androgen deprivation
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Previous Adjuvant Hormone Therapy
Yes
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Previous Adjuvant Hormone Therapy
No
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 2
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Disease Extent
Minimal Disease
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Disease Extent
Extensive Disease
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Comorbidity Score
None
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Comorbidity Score
Mild
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Comorbidity Score
Moderate
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Comorbidity Score
Severe
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsNumber of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
Outcome measures
| Measure |
Risedronate Arm
n=32 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=31 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Numbers of SRE or Death Occurred Cumulatively
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
Risedronate Arm
n=32 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=31 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL
|
50 percentage of participants
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data were collected for this Outcome Measure due to low accrual and subsequent study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: Number of Participants Analyzed reflects participants who had data available prior to study termination.
Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24. Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution. The compounds are detected as a result of their natural fluorescence with a fluorescence detector
Outcome measures
| Measure |
Risedronate Arm
n=22 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=22 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
week 24
|
6.91 nmol/mmol creatinine
Standard Deviation 4.17
|
12.62 nmol/mmol creatinine
Standard Deviation 13.59
|
|
Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)
baseline
|
8.83 nmol/mmol creatinine
Standard Deviation 20.53
|
10.12 nmol/mmol creatinine
Standard Deviation 31.83
|
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
Risedronate Arm
n=32 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=31 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Three- Year Survival Rate
|
72.5 percentage of participants
Interval 55.1 to 89.9
|
71.5 percentage of participants
Interval 51.5 to 91.5
|
SECONDARY outcome
Timeframe: 24 weekPopulation: Number of Participants Analyzed reflects participants who had data available prior to study termination.
Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson \& Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson \& Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction.
Outcome measures
| Measure |
Risedronate Arm
n=20 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=19 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
at 24 week
|
20.63 nmol BCE/mmol creatinine
Standard Deviation 9.15
|
62.95 nmol BCE/mmol creatinine
Standard Deviation 151.67
|
|
Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median
baseline
|
41.33 nmol BCE/mmol creatinine
Standard Deviation 325.87
|
48.08 nmol BCE/mmol creatinine
Standard Deviation 691.70
|
SECONDARY outcome
Timeframe: 24 weekPopulation: Number of Participants Analyzed reflects participants who had data available prior to study termination.
Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve
Outcome measures
| Measure |
Risedronate Arm
n=19 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=17 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Bone Turnover Marker Changes-- Serum BAP
24 week
|
9.5 ng/mL
Standard Deviation 4.59
|
13.16 ng/mL
Standard Deviation 54.62
|
|
Bone Turnover Marker Changes-- Serum BAP
baseline
|
20.95 ng/mL
Standard Deviation 229.68
|
19.50 ng/mL
Standard Deviation 272.98
|
SECONDARY outcome
Timeframe: 24 weekPopulation: Number of Participants Analyzed reflects participants who had data available prior to study termination.
Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.
Outcome measures
| Measure |
Risedronate Arm
n=19 Participants
Daily oral risedronate combined with androgen deprivation
Risedronate: Daily oral risedronate combined with androgen deprivation
|
Placebo Arm
n=18 Participants
daily oral placebo combined with androgen deprivation
Placebo: Daily oral placebo combined with androgen deprivation
|
|---|---|---|
|
Bone Turnover Marker Changes-- Serum Osteocalcin (OC)
at 24 week
|
11.88 ug/L
Standard Deviation 14.94
|
27.35 ug/L
Standard Deviation 57.43
|
|
Bone Turnover Marker Changes-- Serum Osteocalcin (OC)
baseline
|
20.08 ug/L
Standard Deviation 38.36
|
18.24 ug/L
Standard Deviation 43.06
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Risedronate
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
daily oral placebo combined with androgen deprivation
|
Risedronate
n=32 participants at risk
Daily oral risedronate combined with androgen deprivation
|
|---|---|---|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Cardiac disorders
CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK / AV BLOCK-THIRD DEGREE (COMPLETE AV BLOCK)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
DEHYDRATION
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
PAIN / PAIN NOS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
PERFORATION, GU / KIDNEY
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Blood and lymphatic system disorders
PLATELETS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
RENAL FAILURE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI / BILIARY TREE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Vascular disorders
VESSEL INJURY-ARTERY / AORTA
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
daily oral placebo combined with androgen deprivation
|
Risedronate
n=32 participants at risk
Daily oral risedronate combined with androgen deprivation
|
|---|---|---|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
6.5%
2/31 • Number of events 3 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Gastrointestinal disorders
ANOREXIA
|
3.2%
1/31 • Number of events 1 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
3.2%
1/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
3.2%
1/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
BURN
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Eye disorders
CATARACT
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINE-RANGE OF MOTION
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Nervous system disorders
CONFUSION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.8%
8/31 • Number of events 8 • 36 Months
|
25.0%
8/32 • Number of events 9 • 36 Months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
19.4%
6/31 • Number of events 6 • 36 Months
|
12.5%
4/32 • Number of events 9 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.1%
5/31 • Number of events 7 • 36 Months
|
12.5%
4/32 • Number of events 5 • 36 Months
|
|
Investigations
CREATININE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
16.1%
5/31 • Number of events 5 • 36 Months
|
9.4%
3/32 • Number of events 5 • 36 Months
|
|
Gastrointestinal disorders
DIARRHEA
|
9.7%
3/31 • Number of events 3 • 36 Months
|
15.6%
5/32 • Number of events 8 • 36 Months
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Nervous system disorders
DIZZINESS
|
6.5%
2/31 • Number of events 2 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
9.7%
3/31 • Number of events 3 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/31 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
12.9%
4/31 • Number of events 5 • 36 Months
|
12.5%
4/32 • Number of events 4 • 36 Months
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
16.1%
5/31 • Number of events 6 • 36 Months
|
15.6%
5/32 • Number of events 6 • 36 Months
|
|
Endocrine disorders
ENDOCRINE - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY-LOWER (GAIT/WALKING)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY-UPPER (FUNCTION)
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
41.9%
13/31 • Number of events 19 • 36 Months
|
37.5%
12/32 • Number of events 15 • 36 Months
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
6.5%
2/31 • Number of events 2 • 36 Months
|
12.5%
4/32 • Number of events 6 • 36 Months
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
9.7%
3/31 • Number of events 6 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Reproductive system and breast disorders
GYNECOMASTIA
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
3.2%
1/31 • Number of events 2 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
12.9%
4/31 • Number of events 4 • 36 Months
|
18.8%
6/32 • Number of events 6 • 36 Months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
9.7%
3/31 • Number of events 3 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Renal and urinary disorders
HEMORRHAGE, GU / URINARY NOS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
51.6%
16/31 • Number of events 17 • 36 Months
|
50.0%
16/32 • Number of events 20 • 36 Months
|
|
Cardiac disorders
HYPERTENSION
|
16.1%
5/31 • Number of events 6 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Renal and urinary disorders
INCONTINENCE, URINARY
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / MIDDLE EAR (OTITIS MEDIA)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / JOINT
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / NERVE-PERIPHERAL
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / PENIS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / UNGUAL (NAILS)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / WOUND
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE REACTION/EXTRAVASATION CHANGES
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
INSOMNIA
|
19.4%
6/31 • Number of events 7 • 36 Months
|
15.6%
5/32 • Number of events 5 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
JOINT-EFFUSION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
JOINT-FUNCTION
|
9.7%
3/31 • Number of events 4 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
LEAK (INCLUDING ANASTOMOTIC), GU / URETHRA
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINE-RANGE OF MOTION
|
3.2%
1/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
9.7%
3/31 • Number of events 3 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
16.1%
5/31 • Number of events 5 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
9.7%
3/31 • Number of events 3 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / RIGHT-SIDED
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
|
9.7%
3/31 • Number of events 4 • 36 Months
|
18.8%
6/32 • Number of events 11 • 36 Months
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Gastrointestinal disorders
NAUSEA
|
12.9%
4/31 • Number of events 5 • 36 Months
|
15.6%
5/32 • Number of events 6 • 36 Months
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Nervous system disorders
NEUROPATHY: CRANIAL / CN VII MOTOR-FACE; SENSORY-TASTE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
19.4%
6/31 • Number of events 9 • 36 Months
|
18.8%
6/32 • Number of events 8 • 36 Months
|
|
General disorders
OBESITY
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Renal and urinary disorders
OBSTRUCTION, GU / URETER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Ear and labyrinth disorders
OTITIS, MIDDLE EAR (NON-INFECTIOUS)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
PAIN / BACK
|
19.4%
6/31 • Number of events 7 • 36 Months
|
31.2%
10/32 • Number of events 12 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
12.9%
4/31 • Number of events 6 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
PAIN / BREAST
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
12.9%
4/31 • Number of events 5 • 36 Months
|
15.6%
5/32 • Number of events 8 • 36 Months
|
|
General disorders
PAIN / HEAD/HEADACHE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
19.4%
6/31 • Number of events 9 • 36 Months
|
15.6%
5/32 • Number of events 10 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
General disorders
PAIN / NECK
|
6.5%
2/31 • Number of events 2 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
General disorders
PAIN / PAIN NOS
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 3 • 36 Months
|
|
Reproductive system and breast disorders
PAIN / PENIS
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
PAIN / SCROTUM
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Reproductive system and breast disorders
PAIN / TESTICLE
|
6.5%
2/31 • Number of events 2 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
PAIN - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
9.4%
3/32 • Number of events 6 • 36 Months
|
|
Blood and lymphatic system disorders
PLATELETS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
16.1%
5/31 • Number of events 5 • 36 Months
|
6.2%
2/32 • Number of events 3 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
3.2%
1/31 • Number of events 1 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
9.7%
3/31 • Number of events 4 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
3.2%
1/31 • Number of events 1 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
9.7%
3/31 • Number of events 6 • 36 Months
|
9.4%
3/32 • Number of events 3 • 36 Months
|
|
Cardiac disorders
RESTRICTIVE CARDIOMYOPATHY
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 2 • 36 Months
|
|
Skin and subcutaneous tissue disorders
RIGHT FOREARM LESION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SECONDARY MALIGNANCY - POSSIBLY RELATED TO CANCER TREATMENT (SPECIFY, __)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Nervous system disorders
SEIZURE
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
SWEATING (DIAPHORESIS)
|
9.7%
3/31 • Number of events 4 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Vascular disorders
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
0.00%
0/31 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
22.6%
7/31 • Number of events 8 • 36 Months
|
21.9%
7/32 • Number of events 8 • 36 Months
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
3.2%
1/31 • Number of events 1 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
VOMITING
|
6.5%
2/31 • Number of events 3 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
0.00%
0/31 • 36 Months
|
3.1%
1/32 • Number of events 1 • 36 Months
|
|
General disorders
WEIGHT GAIN
|
3.2%
1/31 • Number of events 3 • 36 Months
|
0.00%
0/32 • 36 Months
|
|
General disorders
WEIGHT LOSS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
6.2%
2/32 • Number of events 2 • 36 Months
|
|
Skin and subcutaneous tissue disorders
WOUND COMPLICATION, NON-INFECTIOUS
|
3.2%
1/31 • Number of events 1 • 36 Months
|
0.00%
0/32 • 36 Months
|
Additional Information
Christopher Sweeney, M.B., B.S.
Hoosier Oncology Group
Phone: (617) 632 4524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place