Trial Outcomes & Findings for Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT (NCT NCT03777982)
NCT ID: NCT03777982
Last Updated: 2024-09-19
Results Overview
the composite of metastasis or any cause death
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
* LHRH agonist or antagonist should be prescribed per standard of care
* Abiraterone acetate will be taken once daily
* Prednisone will be taken twice daily
* Apalutamide will be taken once daily
Prednisone: Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
Apalutamide: Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
Abiraterone Acetate: Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
LHRH Agonist or Antagonist
-LHRH agonist or antagonist should be prescribed per standard of care
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
* LHRH agonist or antagonist should be prescribed per standard of care
* Abiraterone acetate will be taken once daily
* Prednisone will be taken twice daily
* Apalutamide will be taken once daily
Prednisone: Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
Apalutamide: Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
Abiraterone Acetate: Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
LHRH Agonist or Antagonist
-LHRH agonist or antagonist should be prescribed per standard of care
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT
Baseline characteristics by cohort
| Measure |
LHRH Agonist or Antagonist
n=6 Participants
-LHRH agonist or antagonist should be prescribed per standard of care
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
n=6 Participants
* LHRH agonist or antagonist should be prescribed per standard of care
* Abiraterone acetate will be taken once daily
* Prednisone will be taken twice daily
* Apalutamide will be taken once daily
Prednisone: Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
Apalutamide: Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
Abiraterone Acetate: Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
70 years
n=5 Participants
|
72 years
n=7 Participants
|
71 years
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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PSA pre-registration
PSA <0.5 ng/mL
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
PSA pre-registration
PSA >=0.5 ng/mL
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
the composite of metastasis or any cause death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
PSA nadir is defined as the lowest PSA after RT completion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
Castrate resistant PSA failure is defined as the first PSA increase that is ≥ 25% and 2 ng/mL above the nadir, which is confirmed by a second value 3 or more weeks later, while the serum total testosterone level is \< 50 ng/dl (per the PCWG2 criteria).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
Prostate cancer specific survival is defined the time from randomization to death from prostate cancer where death due to other causes are considered as competing risk, or censored at the last date of follow up in living patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
Overall survival is defined as the time from randomization to death from any cause with men censored at time of last follow up if alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The trial was terminated before the outcome measure data were collected.
Disease free survival is measured from the date of randomization to the first recorded disease recurrence consisting of castrate resistant PSA failure and/or local, regional or distant failure and death from any cause, whichever comes first, or censored at the date of last disease assessment for those alive and disease recurrence free.
Outcome measures
Outcome data not reported
Adverse Events
LHRH Agonist or Antagonist
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LHRH Agonist or Antagonist
n=6 participants at risk
-LHRH agonist or antagonist should be prescribed per standard of care
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
n=6 participants at risk
* LHRH agonist or antagonist should be prescribed per standard of care
* Abiraterone acetate will be taken once daily
* Prednisone will be taken twice daily
* Apalutamide will be taken once daily
Prednisone: Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
Apalutamide: Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
Abiraterone Acetate: Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
LHRH Agonist or Antagonist: Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
50.0%
3/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
100.0%
6/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
General disorders
Localized edema
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
General disorders
Pain
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Infections and infestations
Nail infection
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
Weight gain
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
66.7%
4/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
66.7%
4/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Psychiatric disorders
Libido decreased
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Vascular disorders
Hot flashes
|
66.7%
4/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
100.0%
6/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
100.0%
6/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
16.7%
1/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
0.00%
0/6 • Toxicities were assessed every cycle. It was measured up to 3.8 years.
Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important defined as a serious adverse event. All other events are defined as other adverse event.
|
Additional Information
Anthony D'Amico
Dana Farber/Mass General Brigham Cancer Care
Phone: 857-215-1489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place