Trial Outcomes & Findings for Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy (NCT NCT00582556)
NCT ID: NCT00582556
Last Updated: 2019-11-26
Results Overview
Effects on bone mineral density were measured at four locations at six month intervals for 24 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
2 years
Results posted on
2019-11-26
Participant Flow
Subjects were screened and enrolled at the University of Wisconsin Carbone Cancer Center from April 2003 until March 2011.
Of the 44 subjects enrolled, one withdrew from the study prior to receiving any study treatment. As a result there were 43 subjects who received at least one dose of study medication.
Participant milestones
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly x 6 Months
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly x 6 Months
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy
Baseline characteristics by cohort
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly x 6 Months
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Gleason Score of 8 or more
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
Participants with evidence of osteopenia/osteoporosis
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
15 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 2 yearsEffects on bone mineral density were measured at four locations at six month intervals for 24 months.
Outcome measures
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly, Months 6-11
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.
|
14 participants
|
15 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 2 yearsSerum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.
Outcome measures
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly, Months 6-11
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 YearsImmune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.
Outcome measures
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly, Months 6-11
n=15 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Number of Subjects Had a Significant Change in Immune Markers.
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 YearsPSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy. Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid.
Outcome measures
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 Participants
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly, Months 6-11
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy
|
0 participants
|
—
|
—
|
Adverse Events
Zometa Given 7 Days Prior to Beginning ADT
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Zometa Given at Month 6
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Zometa Given Monthly x 6 Months
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly x 6 Months
n=15 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Low Platelets
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Metabolism and nutrition disorders
Creatine phosphokinase
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Complication of prior hip replacement)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
General disorders
Chest Pain (non-cardiac and non-pleuritic)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other (fracture)
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Renal and urinary disorders
Creatinine
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-other (shoulder)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/14 • 6 years and 7 months
|
|
Nervous system disorders
Syncope (fainting)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Right Hip Replacement
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain - abdomen
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Vascular disorders
Epidural hematoma
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Infections and infestations
Pulmonary-Other (pneumonia)
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
Other adverse events
| Measure |
Zometa Given 7 Days Prior to Beginning ADT
n=14 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
|
Zometa Given at Month 6
n=15 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
|
Zometa Given Monthly x 6 Months
n=15 participants at risk
GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
|
|---|---|---|---|
|
Endocrine disorders
Hot flashes
|
78.6%
11/14 • Number of events 14 • 6 years and 7 months
|
73.3%
11/15 • Number of events 13 • 6 years and 7 months
|
73.3%
11/15 • Number of events 14 • 6 years and 7 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
7/14 • Number of events 11 • 6 years and 7 months
|
33.3%
5/15 • Number of events 6 • 6 years and 7 months
|
20.0%
3/15 • Number of events 8 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
42.9%
6/14 • Number of events 6 • 6 years and 7 months
|
20.0%
3/15 • Number of events 4 • 6 years and 7 months
|
33.3%
5/15 • Number of events 7 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
6/14 • Number of events 13 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
20.0%
3/15 • Number of events 6 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain - other
|
14.3%
2/14 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 4 • 6 years and 7 months
|
26.7%
4/15 • Number of events 8 • 6 years and 7 months
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 4 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
40.0%
6/15 • Number of events 8 • 6 years and 7 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
20.0%
3/15 • Number of events 4 • 6 years and 7 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
0.00%
0/14 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
2/14 • Number of events 2 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Gastrointestinal disorders
Taste Disturbance (dysgeusia)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Nervous system disorders
Neuropathy-sensory
|
28.6%
4/14 • Number of events 4 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
13.3%
2/15 • Number of events 4 • 6 years and 7 months
|
|
Nervous system disorders
Mood alteration-depression
|
7.1%
1/14 • Number of events 3 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
|
Nervous system disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Nervous system disorders
Neurology--other
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Nervous system disorders
Syncope (fainting)
|
7.1%
1/14 • Number of events 2 • 6 years and 7 months
|
6.7%
1/15 • Number of events 3 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Nervous system disorders
Memory Loss
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Nervous system disorders
Mood alteration-anxiety, agitation
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
14.3%
2/14 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 4 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Renal and urinary disorders
Creatinine
|
14.3%
2/14 • Number of events 3 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Renal and urinary disorders
Incontinence
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Cardiac disorders
Edema
|
21.4%
3/14 • Number of events 3 • 6 years and 7 months
|
33.3%
5/15 • Number of events 5 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
|
Cardiac disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
14.3%
2/14 • Number of events 2 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
13.3%
2/15 • Number of events 3 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 2 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
General disorders
Fatigue
|
42.9%
6/14 • Number of events 6 • 6 years and 7 months
|
53.3%
8/15 • Number of events 9 • 6 years and 7 months
|
46.7%
7/15 • Number of events 12 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
weight gain
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
13.3%
2/15 • Number of events 3 • 6 years and 7 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
14.3%
2/14 • Number of events 2 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
General disorders
Rigors (chills)
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 2 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
General disorders
Sweating (diaphoresis)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
General disorders
Constitutional Symptoms
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Investigations
Weight loss
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/14 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Ear and labyrinth disorders
Auditory/Hearing-Other (hearing loss from broken vessel in ear)
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • 6 years and 7 months
|
13.3%
2/15 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
|
Infections and infestations
Infection without neutropenia
|
7.1%
1/14 • Number of events 2 • 6 years and 7 months
|
20.0%
3/15 • Number of events 3 • 6 years and 7 months
|
20.0%
3/15 • Number of events 4 • 6 years and 7 months
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 2 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Eye disorders
Blurred vision
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Eye disorders
Vision - flashing lights/floaters
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
Creatine phosphokinase
|
7.1%
1/14 • Number of events 3 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
Hypercalcemia
|
0.00%
0/14 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
Hyperglycemia
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Reproductive system and breast disorders
Erectile impotence
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/14 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
6.7%
1/15 • Number of events 1 • 6 years and 7 months
|
|
Investigations
Low Hemoglobin
|
7.1%
1/14 • Number of events 2 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
Low Leukocytes
|
7.1%
1/14 • Number of events 3 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
Low Platelets
|
7.1%
1/14 • Number of events 3 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
SGOT (AST)
|
7.1%
1/14 • Number of events 4 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
|
Investigations
SGPT (ALT)
|
7.1%
1/14 • Number of events 1 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
0.00%
0/15 • 6 years and 7 months
|
Additional Information
Dr. Douglas McNeel
University of Wisconsin Carbone Cancer Center
Phone: 608-263-4198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place