Trial Outcomes & Findings for Ketoconazole and Dexamethasone in Prostate Cancer (NCT NCT01036594)
NCT ID: NCT01036594
Last Updated: 2020-06-29
Results Overview
The number of participants who experience a ≥30% decline in PSA between the time of first progression on ketoconazole and hydrocortisone and eight weeks after dexamethasone therapy was initiated.
COMPLETED
PHASE2
32 participants
Up to 5 years
2020-06-29
Participant Flow
Participants were recruited through the Urologic Oncology Program at University of California, San Francisco
All participants were prescribed ketoconazole for a 7 day run-in phase, then hydrocortisone + ketoconazole treatment. Participants not achieving \>=30% PSA decline at 12 weeks were taken off study. Participants continued treatment until progression at which time, hydrocortisone was discontinued and ketoconazole + dexamethasone treatment began.
Participant milestones
| Measure |
Ketoconazole + Hydrocortisone
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during run-in phase, then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If participant has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by Prostate Specific Antigen Working Group (PSAWG) criteria) is documented. After that, drug will be discontinued. If participant has \< 30% PSA decline at 12 week evaluation, participant goes off study.
|
Ketoconazole + Dexamethasone
Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|---|
|
Run-In: Ketoconazole Only (200 mg)
STARTED
|
32
|
0
|
|
Run-In: Ketoconazole Only (200 mg)
COMPLETED
|
31
|
0
|
|
Run-In: Ketoconazole Only (200 mg)
NOT COMPLETED
|
1
|
0
|
|
First Treatment Regimen
STARTED
|
31
|
0
|
|
First Treatment Regimen
COMPLETED
|
30
|
0
|
|
First Treatment Regimen
NOT COMPLETED
|
1
|
0
|
|
Week 12 Evaluation
STARTED
|
30
|
0
|
|
Week 12 Evaluation
COMPLETED
|
24
|
0
|
|
Week 12 Evaluation
NOT COMPLETED
|
6
|
0
|
|
Treatment Regiments Post Week 12
STARTED
|
15
|
9
|
|
Treatment Regiments Post Week 12
COMPLETED
|
13
|
5
|
|
Treatment Regiments Post Week 12
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ketoconazole + Hydrocortisone
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during run-in phase, then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If participant has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by Prostate Specific Antigen Working Group (PSAWG) criteria) is documented. After that, drug will be discontinued. If participant has \< 30% PSA decline at 12 week evaluation, participant goes off study.
|
Ketoconazole + Dexamethasone
Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|---|
|
Run-In: Ketoconazole Only (200 mg)
Adverse Event
|
1
|
0
|
|
First Treatment Regimen
Withdrawal by Subject
|
1
|
0
|
|
Week 12 Evaluation
Adverse Event
|
5
|
0
|
|
Week 12 Evaluation
Physician Decision
|
1
|
0
|
|
Treatment Regiments Post Week 12
Physician Decision
|
1
|
1
|
|
Treatment Regiments Post Week 12
Withdrawal by Subject
|
1
|
0
|
|
Treatment Regiments Post Week 12
Adverse Event
|
0
|
1
|
|
Treatment Regiments Post Week 12
Non-Cancer Disease Complications
|
0
|
1
|
|
Treatment Regiments Post Week 12
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
This measure presents data for the 9 participants that were subsequently randomized to the second treatment arm
Baseline characteristics by cohort
| Measure |
All Patients Who Received Treatment
n=32 Participants
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If participant has \< 30% PSA decline at 12 week evaluation, participant goes off study.
Based on the results of evaluation at 12 weeks , participants were offered to either stay on this regimen or receive
-Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|
|
Age, Customized
50-59 years old
|
7 Participants
n=32 Participants
|
|
Age, Customized
60-69 years old
|
11 Participants
n=32 Participants
|
|
Age, Customized
70-79 years old
|
10 Participants
n=32 Participants
|
|
Age, Customized
80-89 years old
|
4 Participants
n=32 Participants
|
|
Age, Customized
50-59 years
|
1 Participants
n=9 Participants • This measure presents data for the 9 participants that were subsequently randomized to the second treatment arm
|
|
Age, Customized
60-69 years
|
6 Participants
n=9 Participants • This measure presents data for the 9 participants that were subsequently randomized to the second treatment arm
|
|
Age, Customized
70-79 years
|
2 Participants
n=9 Participants • This measure presents data for the 9 participants that were subsequently randomized to the second treatment arm
|
|
Sex: Female, Male
Female
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • This measure presents data for the participants that were subsequently randomized to the second treatment arm
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Progression data for patients not enrolled to Dexamethasone arm are not used in this analysis.
The number of participants who experience a ≥30% decline in PSA between the time of first progression on ketoconazole and hydrocortisone and eight weeks after dexamethasone therapy was initiated.
Outcome measures
| Measure |
Ketoconazole + Hydrocortisone
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has \< 30% PSA decline at 12 week evaluation, patient goes off study.
|
Ketoconazole + Dexamethasone
n=8 Participants
Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|---|
|
Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: ACTH data not collected for this endpoint. Planned statistical analysis could not be performed.
Nonparametric Wilcoxon test for matched pairs will be used to test the difference in ACTH levels from baseline until the time of disease progression for participants taking ketoconazole/hydrocortisone for participants with evaluable laboratory values.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data on duration of castration prior to treatment data not collected. Planned analysis could not be performed.
The Spearman rank correlation will be calculated to explore the relationship between the baseline ACTH level and the duration of castration prior to the start of any ketoconazole therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Testosterone data for this endpoint not collected. Planned statistical analysis could not be performed.
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of testosterone levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in testosterone from progression #1 to progression #2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Estrodiol data for this endpoint not collected. Planned statistical analysis could not be performed.
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of estrodiol levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in estrodiol from progression #1 to progression #2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: AA data not collected for this endpoint. Planned statistical analyses could not be performed.
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of AA levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in AA levels from progression #1 to progression #2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Cortisol data not collected for this endpoint. Planned statistical analysis could not be performed
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of cortisol levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in cortisol levels from progression #1 to progression #2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: DHEA data was not collected for this endpoint. Planned statistical analysis could not be performed.
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of DHEA levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in DHEA levels from progression #1 to progression #2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: DHEA-S data was not collected for this endpoint. Planned statistical analysis could not be performed.
For PSA responders to ketoconazole/ hydrocortisone continuing with dexamethasone treatment after initial disease progression, the overall pattern of DHEA-S levels will be investigated with nonparametric methods for statistical analyses. This will include Friedman's analysis of variance method using ranks for repeated measures. A key comparison using the Wilcoxon test for matched pairs will investigate the change in DHEA-S levels from progression #1 to progression #2.
Outcome measures
Outcome data not reported
Adverse Events
Ketoconazole + Hydrocortisone
Ketoconazole + Dexamethasone
Serious adverse events
| Measure |
Ketoconazole + Hydrocortisone
n=32 participants at risk
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has \< 30% PSA decline at 12 week evaluation, patient goes off study.
|
Ketoconazole + Dexamethasone
n=9 participants at risk
Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Vascular disorders
Peripheral arterial ischemia
|
3.1%
1/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
3.1%
1/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
Obstruction, GU - Ureter
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC - Bladder (urinary)
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Infections and infestations
Infection - Other
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
Other adverse events
| Measure |
Ketoconazole + Hydrocortisone
n=32 participants at risk
po = oral, tid = 3 times per day, qam = every morning, qom = every evening, bid = twice daily, 1 cycle = 28 days
* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If patient has ≥ 30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If patient has \< 30% PSA decline at 12 week evaluation, patient goes off study.
|
Ketoconazole + Dexamethasone
n=9 participants at risk
Ketoconazole: 400mg po tid Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression on Ketoconazole + Hydrocortisone (by RECIST criteria OR by PSAWG criteria) is documented.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
25.0%
8/32 • Number of events 17 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
8/32 • Number of events 13 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.4%
3/32 • Number of events 4 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Radiation
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
18.8%
6/32 • Number of events 9 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Anorexia
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
37.5%
12/32 • Number of events 23 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
General disorders
Insomnia
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
General disorders
Weight gain
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
General disorders
Weight loss
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
General disorders
Edema: limb
|
21.9%
7/32 • Number of events 14 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) increased
|
15.6%
5/32 • Number of events 15 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase) increased
|
18.8%
6/32 • Number of events 9 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Investigations
Creatinine increased
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Gastrointestinal disorders
Abdomen Pain, NOS
|
12.5%
4/32 • Number of events 8 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
9.4%
3/32 • Number of events 4 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
9.4%
3/32 • Number of events 4 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
General disorders
Pain - Other
|
9.4%
3/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
General disorders
Pain - Chest/thorax NOS
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
4/32 • Number of events 8 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
15.6%
5/32 • Number of events 6 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Renal and urinary disorders
Renal/Genitourinary
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Perforation, GU - Kidney
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
3.1%
1/32 • Number of events 1 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC - Joint
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Nervous system disorders
Syncope (fainting)
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Number of events 11 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
11.1%
1/9 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus bradycardia
|
6.2%
2/32 • Number of events 3 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
22.2%
2/9 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Peripheral arterial ischemia
|
6.2%
2/32 • Number of events 2 • Up to 5 years
|
0.00%
0/9 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/32 • Up to 5 years
|
11.1%
1/9 • Number of events 1 • Up to 5 years
|
Additional Information
Dr. Terence Friedlander, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place