Trial Outcomes & Findings for Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer (NCT NCT01525966)
NCT ID: NCT01525966
Last Updated: 2025-03-03
Results Overview
pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
At completion of definitive surgery, up to six months from initial treatment
Results posted on
2025-03-03
Participant Flow
Participants for this study will be recruited from among patients undergoing treatment at City of Hope Cancer Center for stage II/III -- including inflammatory-- breast adenocarcinoma. Patients will be recruited through encounters by the Breast Oncologists in the Department of Medical Oncology and/or Breast Surgical Oncologists of the Department of General Oncological Surgery.
Participant milestones
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At completion of definitive surgery, up to six months from initial treatmentPopulation: Sixty-seven patients met the eligibility criteria for inclusion in this study.
pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38%
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
pCR Rate After Treatment.
pCR
|
32 Participants
|
|
pCR Rate After Treatment.
not reached pCR
|
35 Participants
|
PRIMARY outcome
Timeframe: At completion of definitive surgery, up to six months post-commencement of study chemotherapy.Population: Sixty-seven patients met the eligibility criteria for inclusion in this study.
Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst.
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Residual Cancer Burden (RCB) by Symmans Criteria.
achieved pCR (RCB 0); no residual disease
|
32 Participants
|
|
Residual Cancer Burden (RCB) by Symmans Criteria.
had RCB I; minimal residual disease
|
10 Participants
|
|
Residual Cancer Burden (RCB) by Symmans Criteria.
had RCB II; moderate residual disease
|
19 Participants
|
|
Residual Cancer Burden (RCB) by Symmans Criteria.
had RCB III; extensive residual disease
|
5 Participants
|
|
Residual Cancer Burden (RCB) by Symmans Criteria.
Progressed
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Sixty-seven patients met the eligibility criteria for inclusion in this study.
After adjuvant chemotherapy and before surgery, some patients were given adjuvant radiation.
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Adjuvant Radiation
Radiation before surgery
|
37 Participants
|
|
Adjuvant Radiation
No radiation was given before surgery
|
29 Participants
|
|
Adjuvant Radiation
No radiation and no surgery
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months.Population: Patients eligible for this study.
After having received adjuvant chemotherapy, and possibly radiation, patients underwent surgery.
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Scope of Surgery
Lumpectomy
|
19 Participants
|
|
Scope of Surgery
Mastectomy
|
47 Participants
|
|
Scope of Surgery
No surgery performed due to distant metastasis
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to three years post-commencement of chemotherapy.Population: Sixty-seven patients met the eligibility criteria for inclusion in this study.
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. The corresponding median survival times (with 90% confidence limits) will be determined. Patients' survival times will be measured from the initial date of treatment to the recorded date of death, or most recent follow-up at the end-of-study date.
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Overall Survival
|
90.2 percentage of surviving patients: 3-yr
Interval 77.8 to 95.8
|
SECONDARY outcome
Timeframe: Up to three years.Population: Sixty-seven patients met the eligibility criteria for inclusion in this study.
Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. Patients' survival times will be measured from the initial date of treatment to the recorded date of progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Progression-free Survival
|
87.3 percentage of pts
Interval 58.5 to 90.2
|
Adverse Events
Treatment (Carboplatin and Nab-paclitaxel)
Serious events: 5 serious events
Other events: 67 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 participants at risk
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
10016288-Febrile neutropenia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10016558-Fever
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10046571-Urinary tract infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10012174-Dehydration
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Surgical and medical procedures
10042613-Surgical and medical procedures - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
Other adverse events
| Measure |
Treatment (Carboplatin and Nab-paclitaxel)
n=67 participants at risk
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel albumin-stabilized nanoparticle formulation: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
10002272-Anemia
|
94.0%
63/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Blood and lymphatic system disorders
10016288-Febrile neutropenia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10007541-Cardiac disorders - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10019279-Heart failure
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10033557-Palpitations
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10040741-Sinus bradycardia
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10040752-Sinus tachycardia
|
31.3%
21/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Cardiac disorders
10061589-Aortic valve disease
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Ear and labyrinth disorders
10014020-Ear pain
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Ear and labyrinth disorders
10047340-Vertigo
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Ear and labyrinth disorders
10065838-Middle ear inflammation
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Endocrine disorders
10020705-Hyperparathyroidism
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Endocrine disorders
10020850-Hyperthyroidism
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10005886-Blurred vision
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10010741-Conjunctivitis
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10013774-Dry eye
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10015919-Eye disorders - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10015958-Eye pain
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10016757-Flashing lights
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10016778-Floaters
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Eye disorders
10047848-Watering eyes
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10000060-Abdominal distension
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10000081-Abdominal pain
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10005265-Bloating
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10010774-Constipation
|
35.8%
24/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10012727-Diarrhea
|
23.9%
16/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10013781-Dry mouth
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10013946-Dyspepsia
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10013950-Dysphagia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10016766-Flatulence
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10017947-Gastrointestinal disorders - Other, specify
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10018286-Gingival pain
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10028130-Mucositis oral
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10028813-Nausea
|
59.7%
40/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10030980-Oral hemorrhage
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10031009-Oral pain
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10044055-Toothache
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10047700-Vomiting
|
23.9%
16/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Gastrointestinal disorders
10066874-Gastroesophageal reflux disease
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10008531-Chills
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10016256-Fatigue
|
95.5%
64/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10016558-Fever
|
13.4%
9/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10017577-Gait disturbance
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10022095-Injection site reaction
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10033371-Pain
|
17.9%
12/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10050068-Edema limbs
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10062466-Localized edema
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
General disorders
10062501-Non-cardiac chest pain
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Immune system disorders
10001718-Allergic reaction
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Immune system disorders
10002218-Anaphylaxis
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10007810-Catheter related infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10021881-Infections and infestations - Other, specify
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10040872-Skin infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10046300-Upper respiratory infection
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10046571-Urinary tract infection
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10055078-Bronchial infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10061304-Nail infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10062255-Soft tissue infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10065772-Vulval infection
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Infections and infestations
10069138-Papulopustular rash
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Injury, poisoning and procedural complications
10006504-Bruising
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Injury, poisoning and procedural complications
10016173-Fall
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Injury, poisoning and procedural complications
10048031-Wound dehiscence
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Injury, poisoning and procedural complications
10053692-Wound complication
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Injury, poisoning and procedural complications
10061103-Dermatitis radiation
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10001551-Alanine aminotransferase increased
|
46.3%
31/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10001675-Alkaline phosphatase increased
|
25.4%
17/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10003481-Aspartate aminotransferase increased
|
35.8%
24/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10005364-Blood bilirubin increased
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10007839-CD4 lymphocytes decreased
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10011368-Creatinine increased
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10025256-Lymphocyte count decreased
|
23.9%
16/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10029366-Neutrophil count decreased
|
86.6%
58/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10035528-Platelet count decreased
|
61.2%
41/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10047896-Weight gain
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10047900-Weight loss
|
17.9%
12/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10049182-White blood cell decreased
|
82.1%
55/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Investigations
10050528-Ejection fraction decreased
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10002646-Anorexia
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10012174-Dehydration
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020587-Hypercalcemia
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020639-Hyperglycemia
|
9.0%
6/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020647-Hyperkalemia
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020670-Hypermagnesemia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020680-Hypernatremia
|
11.9%
8/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020870-Hypertriglyceridemia
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020943-Hypoalbuminemia
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10020949-Hypocalcemia
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10021005-Hypoglycemia
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10021018-Hypokalemia
|
23.9%
16/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10021028-Hypomagnesemia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10021038-Hyponatremia
|
19.4%
13/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10021059-Hypophosphatemia
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Metabolism and nutrition disorders
10029883-Obesity
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10003239-Arthralgia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10003988-Back pain
|
11.9%
8/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10006002-Bone pain
|
17.9%
12/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10008496-Chest wall pain
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10016750-Flank pain
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10028411-Myalgia
|
9.0%
6/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10028836-Neck pain
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10031282-Osteoporosis
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10033425-Pain in extremity
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10062572-Generalized muscle weakness
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Musculoskeletal and connective tissue disorders
10065776-Muscle weakness lower limb
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10045158-Tumor pain
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10013573-Dizziness
|
22.4%
15/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10013911-Dysgeusia
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10019211-Headache
|
31.3%
21/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10027175-Memory impairment
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10029205-Nervous system disorders - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10029223-Neuralgia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10033987-Paresthesia
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10034620-Peripheral sensory neuropathy
|
79.1%
53/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10036653-Presyncope
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Nervous system disorders
10044565-Tremor
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Psychiatric disorders
10002855-Anxiety
|
19.4%
13/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Psychiatric disorders
10012378-Depression
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Psychiatric disorders
10022437-Insomnia
|
22.4%
15/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10019450-Hematuria
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10037032-Proteinuria
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10046539-Urinary frequency
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10046543-Urinary incontinence
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10046555-Urinary retention
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10046593-Urinary urgency
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10046628-Urine discoloration
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Renal and urinary disorders
10062225-Urinary tract pain
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10006298-Breast pain
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10022992-Irregular menstruation
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10036601-Premature menopause
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10046901-Vaginal discharge
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10046904-Vaginal dryness
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Reproductive system and breast disorders
10046912-Vaginal hemorrhage
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10001723-Allergic rhinitis
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10011224-Cough
|
9.0%
6/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10013963-Dyspnea
|
13.4%
9/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10015090-Epistaxis
|
6.0%
4/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10028735-Nasal congestion
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10036402-Postnasal drip
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10036790-Productive cough
|
4.5%
3/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10041232-Sneezing
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10041367-Sore throat
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
10047924-Wheezing
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10001760-Alopecia
|
59.7%
40/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10013786-Dry skin
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10020642-Hyperhidrosis
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10028691-Nail discoloration
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10037087-Pruritus
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10037847-Rash acneiform
|
14.9%
10/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10037868-Rash maculo-papular
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10040785-Skin and subcutaneous tissue disorders - Other, specify
|
13.4%
9/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10040865-Skin hyperpigmentation
|
10.4%
7/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Skin and subcutaneous tissue disorders
10062283-Nail ridging
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Social circumstances
10027308-Menopause
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Social circumstances
10041244-Social circumstances - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10016825-Flushing
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10019428-Hematoma
|
3.0%
2/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10020407-Hot flashes
|
20.9%
14/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10020772-Hypertension
|
77.6%
52/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10021097-Hypotension
|
7.5%
5/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
|
Vascular disorders
10047065-Vascular disorders - Other, specify
|
1.5%
1/67 • Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place