Trial Outcomes & Findings for Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer (NCT NCT00930930)
NCT ID: NCT00930930
Last Updated: 2015-05-07
Results Overview
Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
at time of surgery, week 15-18
Results posted on
2015-05-07
Participant Flow
This Vanderbilt-Ingram Cancer Center, multi-site intervention study included 7 additional cancer centers. It opened to enrollment in June 2009 and ran through May 2013.
One hundred forty-seven patients enrolled in this study. Two patients were not eligible to participate.
Participant milestones
| Measure |
Arm I
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Arm II
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
49
|
|
Overall Study
COMPLETED
|
75
|
40
|
|
Overall Study
NOT COMPLETED
|
21
|
9
|
Reasons for withdrawal
| Measure |
Arm I
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Arm II
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
13
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Disease progression
|
2
|
3
|
|
Overall Study
excessive lapse btw txs, not eligible
|
0
|
1
|
|
Overall Study
patients not compliant
|
1
|
1
|
Baseline Characteristics
Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=96 Participants
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Arm II
n=49 Participants
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
52 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
49 participants
n=7 Participants
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of surgery, week 15-18Population: Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders
Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.
Outcome measures
| Measure |
Cisplatin and Paclitaxel + RAD001
n=88 Participants
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Cisplatin and Paclitaxel + Placebo
n=44 Participants
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Number of Patients With Pathological Complete Response
|
34 participants
|
17 participants
|
SECONDARY outcome
Timeframe: at the time of surgery, week 15-18Population: participants that had breast conservation surgery
Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).
Outcome measures
| Measure |
Cisplatin and Paclitaxel + RAD001
n=96 Participants
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Cisplatin and Paclitaxel + Placebo
n=49 Participants
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Number of Patients That Underwent Breast Conservation Surgery
|
38 participants
|
19 participants
|
SECONDARY outcome
Timeframe: After treatment, week 12-15Population: Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Outcome measures
| Measure |
Cisplatin and Paclitaxel + RAD001
n=96 Participants
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Cisplatin and Paclitaxel + Placebo
n=48 Participants
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Complete Response
|
48 participants
|
23 participants
|
|
Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Partial Response
|
27 participants
|
19 participants
|
|
Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Stable Disease
|
18 participants
|
5 participants
|
|
Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Progressive Disease
|
2 participants
|
0 participants
|
|
Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Not Evaluable
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: week 12Population: Total number of patients reported with any toxicity related to study treatment.
Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.
Outcome measures
| Measure |
Cisplatin and Paclitaxel + RAD001
n=96 Participants
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Cisplatin and Paclitaxel + Placebo
n=49 Participants
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Number of Patients With Each Worst-grade Toxicity Response
Number of patients with worst-grade toxicity 1
|
9 participants
|
5 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
Number of patients with worst-grade toxicity 2
|
40 participants
|
28 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
Number of patients with worst-grade toxicity 3
|
39 participants
|
9 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
Number of patients with worst-grade toxicity 4
|
3 participants
|
1 participants
|
|
Number of Patients With Each Worst-grade Toxicity Response
Number of patients with worst-grade toxicity 5
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before treatment, on day 3-5 of week 1, and at week 12To determine the relevance of pathway modulation in triple negative breast cancer cell networking
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Before treatment, on day 3-5 of week 1, and at week 12To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious events: 22 serious events
Other events: 96 other events
Deaths: 0 deaths
Arm II
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=96 participants at risk
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Arm II
n=49 participants at risk
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Immune system disorders
Allergic reaction to study drug
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Gastrointestinal disorders
Dehydration
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Psychiatric disorders
mental status altered
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Cardiac disorders
cardiac ischemia/infarction
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Vascular disorders
cerebrovascular ischemia
|
0.00%
0/96 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Gastrointestinal disorders
colitis
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Investigations
creatinine increased
|
3.1%
3/96 • Number of events 3 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Gastrointestinal disorders
diarrhea
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Nervous system disorders
dizziness
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
General disorders
edema
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
General disorders
fatigue
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
General disorders
Fever with absence of neutropenia
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
flu-like symptoms
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Investigations
hemaglobin increased
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Infections and infestations
infection- respiratory
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
infection with unknown ANC
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/96 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
Seroma
|
0.00%
0/96 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
infection - other
|
0.00%
0/96 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Gastrointestinal disorders
ileus
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
lymphopenia
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Gastrointestinal disorders
nausea
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
General disorders
pain - chest
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
pain - extremity
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Cardiac disorders
sinus tachycardia
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Vascular disorders
syncope
|
2.1%
2/96 • Number of events 2 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Vascular disorders
Thrombosis
|
3.1%
3/96 • Number of events 3 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Gastrointestinal disorders
vomiting
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Renal and urinary disorders
urinary retention
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Gastrointestinal disorders
distal small bowel obstruction
|
1.0%
1/96 • Number of events 1 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
Other adverse events
| Measure |
Arm I
n=96 participants at risk
Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks
cisplatin: Given IV
everolimus: Given orally
paclitaxel: Given IV
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
Arm II
n=49 participants at risk
Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks
cisplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment
|
|---|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
14.6%
14/96 • Number of events 21 • 1 year, 2 months
|
8.2%
4/49 • Number of events 5 • 1 year, 2 months
|
|
Immune system disorders
Allergic reaction - including drug fever
|
14.6%
14/96 • Number of events 14 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
9.4%
9/96 • Number of events 9 • 1 year, 2 months
|
12.2%
6/49 • Number of events 6 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergy - other
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Serum glutamic pyruvic transaminase
|
24.0%
23/96 • Number of events 33 • 1 year, 2 months
|
10.2%
5/49 • Number of events 7 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.3%
7/96 • Number of events 8 • 1 year, 2 months
|
14.3%
7/49 • Number of events 7 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Serum glutamic oxaloacetic transaminase
|
31.2%
30/96 • Number of events 36 • 1 year, 2 months
|
8.2%
4/49 • Number of events 5 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
19.8%
19/96 • Number of events 27 • 1 year, 2 months
|
14.3%
7/49 • Number of events 7 • 1 year, 2 months
|
|
Cardiac disorders
Cardiac General
|
10.4%
10/96 • Number of events 11 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hypercholesteremia
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Gastrointestinal disorders
Constipation
|
36.5%
35/96 • Number of events 38 • 1 year, 2 months
|
38.8%
19/49 • Number of events 20 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.8%
20/96 • Number of events 20 • 1 year, 2 months
|
16.3%
8/49 • Number of events 8 • 1 year, 2 months
|
|
General disorders
General Disorders, other
|
9.4%
9/96 • Number of events 10 • 1 year, 2 months
|
10.2%
5/49 • Number of events 6 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
14/96 • Number of events 15 • 1 year, 2 months
|
10.2%
5/49 • Number of events 5 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Rashes
|
39.6%
38/96 • Number of events 41 • 1 year, 2 months
|
32.7%
16/49 • Number of events 17 • 1 year, 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
45.8%
44/96 • Number of events 49 • 1 year, 2 months
|
26.5%
13/49 • Number of events 14 • 1 year, 2 months
|
|
Nervous system disorders
Dizziness
|
7.3%
7/96 • Number of events 7 • 1 year, 2 months
|
14.3%
7/49 • Number of events 7 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.6%
14/96 • Number of events 14 • 1 year, 2 months
|
14.3%
7/49 • Number of events 8 • 1 year, 2 months
|
|
Renal and urinary disorders
Edema
|
14.6%
14/96 • Number of events 23 • 1 year, 2 months
|
8.2%
4/49 • Number of events 4 • 1 year, 2 months
|
|
General disorders
fatigue
|
71.9%
69/96 • Number of events 83 • 1 year, 2 months
|
73.5%
36/49 • Number of events 44 • 1 year, 2 months
|
|
Vascular disorders
Flushing
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
30.6%
15/49 • Number of events 15 • 1 year, 2 months
|
|
Gastrointestinal disorders
Abdominal cramping
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
12.2%
6/49 • Number of events 7 • 1 year, 2 months
|
|
Gastrointestinal disorders
Heartburn, dyspepsia, reflux, GERD
|
49.0%
47/96 • Number of events 48 • 1 year, 2 months
|
40.8%
20/49 • Number of events 20 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis oral
|
9.4%
9/96 • Number of events 12 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
46.9%
45/96 • Number of events 56 • 1 year, 2 months
|
36.7%
18/49 • Number of events 27 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hypoglycemia
|
4.2%
4/96 • Number of events 4 • 1 year, 2 months
|
6.1%
3/49 • Number of events 5 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
33.3%
32/96 • Number of events 33 • 1 year, 2 months
|
22.4%
11/49 • Number of events 11 • 1 year, 2 months
|
|
Vascular disorders
Hypertension
|
25.0%
24/96 • Number of events 24 • 1 year, 2 months
|
30.6%
15/49 • Number of events 15 • 1 year, 2 months
|
|
Infections and infestations
infection - lung
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
0.00%
0/49 • 1 year, 2 months
|
|
Infections and infestations
Infection - sinus
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Infections and infestations
Infection - Other
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
10.2%
5/49 • Number of events 5 • 1 year, 2 months
|
|
Renal and urinary disorders
infection - urinary
|
7.3%
7/96 • Number of events 7 • 1 year, 2 months
|
2.0%
1/49 • Number of events 1 • 1 year, 2 months
|
|
Psychiatric disorders
Insomnia
|
20.8%
20/96 • Number of events 20 • 1 year, 2 months
|
20.4%
10/49 • Number of events 10 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
68.8%
66/96 • Number of events 104 • 1 year, 2 months
|
65.3%
32/49 • Number of events 33 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.3%
7/96 • Number of events 8 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
11.5%
11/96 • Number of events 11 • 1 year, 2 months
|
14.3%
7/49 • Number of events 7 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - other
|
24.0%
23/96 • Number of events 25 • 1 year, 2 months
|
26.5%
13/49 • Number of events 13 • 1 year, 2 months
|
|
Psychiatric disorders
anxiety
|
29.2%
28/96 • Number of events 28 • 1 year, 2 months
|
20.4%
10/49 • Number of events 10 • 1 year, 2 months
|
|
Psychiatric disorders
depression
|
17.7%
17/96 • Number of events 17 • 1 year, 2 months
|
18.4%
9/49 • Number of events 10 • 1 year, 2 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
38.5%
37/96 • Number of events 37 • 1 year, 2 months
|
18.4%
9/49 • Number of events 9 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - other
|
13.5%
13/96 • Number of events 13 • 1 year, 2 months
|
6.1%
3/49 • Number of events 4 • 1 year, 2 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
64/96 • Number of events 67 • 1 year, 2 months
|
40.8%
20/49 • Number of events 20 • 1 year, 2 months
|
|
Nervous system disorders
neuropathy
|
49.0%
47/96 • Number of events 47 • 1 year, 2 months
|
59.2%
29/49 • Number of events 29 • 1 year, 2 months
|
|
Investigations
Neutropenia
|
53.1%
51/96 • Number of events 63 • 1 year, 2 months
|
34.7%
17/49 • Number of events 19 • 1 year, 2 months
|
|
General disorders
Pain - abdomen
|
3.1%
3/96 • Number of events 3 • 1 year, 2 months
|
8.2%
4/49 • Number of events 5 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
pain - back
|
13.5%
13/96 • Number of events 14 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
General disorders
pain - breast
|
9.4%
9/96 • Number of events 9 • 1 year, 2 months
|
8.2%
4/49 • Number of events 4 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain - extremity
|
10.4%
10/96 • Number of events 10 • 1 year, 2 months
|
22.4%
11/49 • Number of events 11 • 1 year, 2 months
|
|
General disorders
Pain - headache
|
17.7%
17/96 • Number of events 19 • 1 year, 2 months
|
34.7%
17/49 • Number of events 18 • 1 year, 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
7.3%
7/96 • Number of events 8 • 1 year, 2 months
|
12.2%
6/49 • Number of events 6 • 1 year, 2 months
|
|
General disorders
Pain chest
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
General disorders
Pain - other
|
17.7%
17/96 • Number of events 17 • 1 year, 2 months
|
12.2%
6/49 • Number of events 6 • 1 year, 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.7%
40/96 • Number of events 44 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Potassium serum high
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Potassium serum low
|
21.9%
21/96 • Number of events 21 • 1 year, 2 months
|
10.2%
5/49 • Number of events 5 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritus (itching)
|
7.3%
7/96 • Number of events 7 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Nervous system disorders
Neurology - other
|
13.5%
13/96 • Number of events 13 • 1 year, 2 months
|
18.4%
9/49 • Number of events 9 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Desquamation (skin scaling)
|
8.3%
8/96 • Number of events 8 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Skin and subcutaneous tissue disorders
Acne/acneiform
|
19.8%
19/96 • Number of events 19 • 1 year, 2 months
|
8.2%
4/49 • Number of events 4 • 1 year, 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.6%
15/96 • Number of events 15 • 1 year, 2 months
|
22.4%
11/49 • Number of events 12 • 1 year, 2 months
|
|
Nervous system disorders
dysgeusia (taste alteration)
|
9.4%
9/96 • Number of events 10 • 1 year, 2 months
|
28.6%
14/49 • Number of events 15 • 1 year, 2 months
|
|
Endocrine disorders
hypothyroidism
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Reproductive system and breast disorders
Sexual/Reproduction -dryness, soreness, itching
|
7.3%
7/96 • Number of events 7 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
13/96 • Number of events 13 • 1 year, 2 months
|
14.3%
7/49 • Number of events 9 • 1 year, 2 months
|
|
Investigations
weight changes (gain or loss)
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
6.1%
3/49 • Number of events 3 • 1 year, 2 months
|
|
Eye disorders
visual disorders - other
|
10.4%
10/96 • Number of events 10 • 1 year, 2 months
|
8.2%
4/49 • Number of events 4 • 1 year, 2 months
|
|
General disorders
Fever
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
8.3%
8/96 • Number of events 8 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
|
Infections and infestations
Infection - upper respiratory
|
3.1%
3/96 • Number of events 3 • 1 year, 2 months
|
10.2%
5/49 • Number of events 6 • 1 year, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory - other
|
11.5%
11/96 • Number of events 11 • 1 year, 2 months
|
12.2%
6/49 • Number of events 6 • 1 year, 2 months
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
6.2%
6/96 • Number of events 6 • 1 year, 2 months
|
10.2%
5/49 • Number of events 5 • 1 year, 2 months
|
|
Ear and labyrinth disorders
Auditory - other
|
5.2%
5/96 • Number of events 5 • 1 year, 2 months
|
4.1%
2/49 • Number of events 2 • 1 year, 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60