Trial Outcomes & Findings for Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer (NCT NCT00016913)
NCT ID: NCT00016913
Last Updated: 2016-07-06
Results Overview
Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at \>90 days after the completion of radiotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
90 days and 1 year post treatment
Results posted on
2016-07-06
Participant Flow
Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.
Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.
Participant milestones
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
n=27 Participants
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 90 days and 1 year post treatmentPopulation: Final analyses were performed on all 27 eligible patients.
Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at \>90 days after the completion of radiotherapy.
Outcome measures
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
n=27 Participants
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
|---|---|
|
Toxicity
Grade 3+ Toxicity <=90 days post radiotherapy
|
2 Events
|
|
Toxicity
Grade 3+ Toxicity >90 days post radiotherapy
|
0 Events
|
SECONDARY outcome
Timeframe: PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).Population: All 27 evaluable patients were used in this analysis.
PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.
Outcome measures
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
n=27 Participants
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
|---|---|
|
Time to Prostate-specific Antigen Failure
ASTRO criteria
|
12.1 months
Interval 10.3 to 15.7
|
|
Time to Prostate-specific Antigen Failure
CALGB criteria
|
17.1 months
Interval 13.3 to 25.9
|
SECONDARY outcome
Timeframe: registration to progression, up to 5.5 years from registrationPopulation: All 27 evaluable patients were used in this analysis
PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.
Outcome measures
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
n=27 Participants
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
|---|---|
|
Progression-free Survival (PFS)
|
12.1 months
Interval 10.3 to 15.7
|
Adverse Events
Neo-Adj ChemoTx + Ablation Prior to RT
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neo-Adj ChemoTx + Ablation Prior to RT
n=29 participants at risk
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
31.0%
9/29 • Number of events 10
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Blood and lymphatic system disorders
Blood disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
93.1%
27/29 • Number of events 106
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.9%
2/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Cardiac disorders
Edema
|
48.3%
14/29 • Number of events 31
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Cardiac disorders
Left ventricular failure
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Ear and labyrinth disorders
Ear disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Endocrine disorders
Endocrine disorder
|
10.3%
3/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Eye disorders
Diplopia
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Eye disorders
Eye disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Eye disorders
Vision blurred
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.2%
5/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
62.1%
18/29 • Number of events 27
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
58.6%
17/29 • Number of events 36
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
13.8%
4/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.7%
6/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.9%
2/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
17.2%
5/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
58.6%
17/29 • Number of events 29
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Proctitis
|
20.7%
6/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
24.1%
7/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Rectal pain
|
20.7%
6/29 • Number of events 12
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Tooth disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
7/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Chest pain
|
6.9%
2/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Fatigue
|
86.2%
25/29 • Number of events 102
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Fever
|
13.8%
4/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
General symptom
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Ill-defined disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Localized edema
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Pain
|
27.6%
8/29 • Number of events 21
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
General disorders
Radiation-Other(Specify,_____)
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Infections and infestations
Catheter related infection
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Infections and infestations
Infection without neutropenia
|
27.6%
8/29 • Number of events 10
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Infections and infestations
Nail infection
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Infections and infestations
Urethral infection
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.0%
9/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
37.9%
11/29 • Number of events 15
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Alkaline phosphatase
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
31.0%
9/29 • Number of events 22
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Blood bilirubin increased
|
17.2%
5/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Coagulopathy
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Creatine phosphokinase increased
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Creatinine increased
|
44.8%
13/29 • Number of events 24
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Forced expiratory volume decreased
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
INR increased
|
51.7%
15/29 • Number of events 17
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Laboratory test abnormal
|
3.4%
1/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Leukocyte count decreased
|
62.1%
18/29 • Number of events 58
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
31.0%
9/29 • Number of events 35
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Neutrophil count decreased
|
34.5%
10/29 • Number of events 12
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Platelet count decreased
|
51.7%
15/29 • Number of events 34
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Serum cholesterol increased
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Weight gain
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Investigations
Weight loss
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
79.3%
23/29 • Number of events 71
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
34.5%
10/29 • Number of events 23
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
48.3%
14/29 • Number of events 29
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.9%
2/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.3%
3/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
17.2%
5/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
13.8%
4/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
13.8%
4/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
44.8%
13/29 • Number of events 24
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.7%
6/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.9%
2/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
4/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
3/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
13.8%
4/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.7%
6/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • Number of events 7
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
24.1%
7/29 • Number of events 8
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Extrapyramidal disorder
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Headache
|
24.1%
7/29 • Number of events 9
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Neuralgia
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Neurological disorder NOS
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
62.1%
18/29 • Number of events 57
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Psychiatric disorders
Depression
|
6.9%
2/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Psychiatric disorders
Insomnia
|
27.6%
8/29 • Number of events 11
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Psychiatric disorders
Libido decreased
|
10.3%
3/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Psychiatric disorders
Personality change
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Bladder spasm
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Cystitis
|
10.3%
3/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
48.3%
14/29 • Number of events 30
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
31.0%
9/29 • Number of events 12
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Incontinence
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Ureteric perforation
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
89.7%
26/29 • Number of events 113
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
20.7%
6/29 • Number of events 10
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Urine discoloration
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Renal and urinary disorders
Urogenital disorder
|
13.8%
4/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
44.8%
13/29 • Number of events 36
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Reproductive system and breast disorders
Gynecomastia
|
17.2%
5/29 • Number of events 16
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Reproductive system and breast disorders
Penile pain
|
3.4%
1/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Number of events 6
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • Number of events 8
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
48.3%
14/29 • Number of events 27
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.0%
9/29 • Number of events 16
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.6%
8/29 • Number of events 15
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
3/29 • Number of events 4
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.2%
5/29 • Number of events 12
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
10.3%
3/29 • Number of events 3
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Number of events 1
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Vascular disorders
Hot flashes
|
44.8%
13/29 • Number of events 23
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Vascular disorders
Hypertension
|
13.8%
4/29 • Number of events 5
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
|
Vascular disorders
Phlebitis
|
6.9%
2/29 • Number of events 2
All patients that received protocol treatment were analyzed for Adverse Events. Of the 34 patients that enrolled, 4 patients did not have radiotherapy and 1 patient was not evaluated for adverse events. Therefore, 29 patients were evaluated for adverse events.
|
Additional Information
Wm. Kevin Kelly, DO
Department of Medicine, Memorial Sloan-Kettering Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place