Trial Outcomes & Findings for S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer (NCT NCT00075764)
NCT ID: NCT00075764
Last Updated: 2021-01-13
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
695 participants
Primary outcome timeframe
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Results posted on
2021-01-13
Participant Flow
707 Patients underwent randomization. 12 were excluded: 9 did not have metastatic disease, 1 had previous chemotherapy, 1 was estrogen-receptor and progesterone-receptor negative, 1 did not undergo chest imaging. In addition, 1 patient withdrew consent. 694 patients were included in the analysis.
Participant milestones
| Measure |
Arm I Anastrozole
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Overall Study
STARTED
|
345
|
349
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
345
|
349
|
Reasons for withdrawal
| Measure |
Arm I Anastrozole
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
12
|
|
Overall Study
Death
|
4
|
8
|
|
Overall Study
Withdrawal by Subject
|
28
|
18
|
|
Overall Study
Progression
|
269
|
274
|
|
Overall Study
Still on treatment
|
8
|
15
|
|
Overall Study
Delinquent
|
4
|
2
|
|
Overall Study
Not protocol specified
|
27
|
19
|
|
Overall Study
Under review
|
0
|
1
|
Baseline Characteristics
Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
Baseline characteristics by cohort
| Measure |
Arm I Anastrozole
n=345 Participants
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
n=349 Participants
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
Total
n=694 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=345 Participants
|
65 years
n=349 Participants
|
65 years
n=694 Participants
|
|
Sex: Female, Male
Female
|
345 Participants
n=345 Participants
|
349 Participants
n=349 Participants
|
694 Participants
n=694 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=345 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=694 Participants
|
|
Prior adjuvant tamoxifen
Yes
|
139 participants
n=345 Participants
|
141 participants
n=349 Participants
|
280 participants
n=694 Participants
|
|
Prior adjuvant tamoxifen
No
|
206 participants
n=345 Participants
|
208 participants
n=349 Participants
|
414 participants
n=694 Participants
|
|
Prior adjuvant chemotherapy
Yes
|
103 participants
n=345 Participants
|
129 participants
n=349 Participants
|
232 participants
n=694 Participants
|
|
Prior adjuvant chemotherapy
No
|
242 participants
n=345 Participants
|
220 participants
n=349 Participants
|
462 participants
n=694 Participants
|
|
Measurable disease
Yes
|
188 participants
n=345 Participants
|
188 participants
n=349 Participants
|
376 participants
n=694 Participants
|
|
Measurable disease
No
|
157 participants
n=345 Participants
|
161 participants
n=349 Participants
|
318 participants
n=694 Participants
|
|
Disease site
Bone only
|
76 participants
n=345 Participants
|
75 participants
n=349 Participants
|
151 participants
n=694 Participants
|
|
Disease site
Visceral
|
167 participants
n=345 Participants
|
181 participants
n=349 Participants
|
348 participants
n=694 Participants
|
|
Disease site
Nonvisceral
|
102 participants
n=345 Participants
|
93 participants
n=349 Participants
|
195 participants
n=694 Participants
|
|
Time between diagnosis of primary and metastatic disease
None
|
141 participants
n=337 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
122 participants
n=339 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
263 participants
n=676 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
|
Time between diagnosis of primary and metastatic disease
3 mo to < 5 yr
|
40 participants
n=337 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
47 participants
n=339 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
87 participants
n=676 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
|
Time between diagnosis of primary and metastatic disease
5 to < 10 yr
|
68 participants
n=337 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
66 participants
n=339 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
134 participants
n=676 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
|
Time between diagnosis of primary and metastatic disease
>= 10 yr
|
88 participants
n=337 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
104 participants
n=339 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
192 participants
n=676 Participants • Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
|
|
HER2 status
Positive
|
25 participants
n=295 Participants • Only patients with available HER2 status data will be included in the analysis.
|
31 participants
n=297 Participants • Only patients with available HER2 status data will be included in the analysis.
|
56 participants
n=592 Participants • Only patients with available HER2 status data will be included in the analysis.
|
|
HER2 status
Negative
|
270 participants
n=295 Participants • Only patients with available HER2 status data will be included in the analysis.
|
266 participants
n=297 Participants • Only patients with available HER2 status data will be included in the analysis.
|
536 participants
n=592 Participants • Only patients with available HER2 status data will be included in the analysis.
|
PRIMARY outcome
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.
Outcome measures
| Measure |
Arm I Anastrozole
n=345 Participants
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
n=349 Participants
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Time to Tumor Progression
|
13.5 months
Interval 12.1 to 15.1
|
15.0 months
Interval 13.2 to 18.4
|
SECONDARY outcome
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable \>= 24 weeks
Outcome measures
| Measure |
Arm I Anastrozole
n=345 Participants
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
n=349 Participants
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
|
70 percentage of participants
|
73 percentage of participants
|
SECONDARY outcome
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.
Outcome measures
| Measure |
Arm I Anastrozole
n=345 Participants
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
n=349 Participants
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Overall Survival
|
41.3 months
Interval 37.2 to 45.0
|
47.7 months
Interval 43.4 to 55.7
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.Population: Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)
Outcome measures
| Measure |
Arm I Anastrozole
n=337 Participants
Patients receive oral anastrozole once daily on days 1-28.
anastrozole: Given orally
|
Arm II Anastrozole and Fulvestrant
n=348 Participants
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
anastrozole: Given orally
fulvestrant: Given intramuscularly
|
|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bilirubin (hyperbilirubinemia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fracture
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: sensory
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest/thorax NOS
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain-Other (Specify)
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelets
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
AST, SGOT
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CNS cerebrovascular ischemia
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Calcium, serum-high (hypercalcemia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cataract
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema: limb
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
7 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Glucose, serum-high (hyperglycemia)
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemoglobin
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemolysis
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes/flushes
|
2 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Urinary tract NOS
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint-effusion
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
3 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Memory impairment
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - agitation
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - anxiety
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - depression
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Pharynx
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neurology-Other (Specify)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Back
|
5 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Bone
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Breast
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Buttock
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest wall
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Extremity-limb
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Joint
|
5 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Muscle
|
3 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Neck
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Pelvis
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash/desquamation
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Speech impairment (e.g., dysphasia or aphasia)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sudden death
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope (fainting)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/embolism (vascular access-related)
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
6 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tinnitus
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tumor flare
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urticaria (hives, welts, wheals)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
3 Participants
|
2 Participants
|
Adverse Events
Anastrozole
Serious events: 21 serious events
Other events: 309 other events
Deaths: 0 deaths
Anastrozole & Fulvestrant
Serious events: 48 serious events
Other events: 322 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anastrozole
n=337 participants at risk
Patients receive oral anastrozole once daily on days 1-28
|
Anastrozole & Fulvestrant
n=348 participants at risk
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.59%
2/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Cardiac disorders
Atrioventricular block - 2nd degree Mobitz Type II
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.00%
0/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.00%
0/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.86%
3/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Diarrhea
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Obstruction, GI - Ileum
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Perforation, GI - Colon
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
2/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Pain-Other
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Sudden death
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Bone
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Pleura
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.86%
3/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Infection with unknown ANC - Rectum
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.86%
3/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
1.4%
5/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Leukocytes (total WBC)
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.00%
0/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Platelets
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
1.7%
6/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
1.1%
4/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.86%
3/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
3.0%
10/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
1.1%
4/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.00%
0/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Neurology-Other
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Confusion
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Mood alteration - agitation
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.00%
0/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.5%
5/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.59%
2/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pleura
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.29%
1/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Vascular disorders
Hypotension
|
0.00%
0/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
0.57%
2/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.30%
1/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
1.4%
5/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
Other adverse events
| Measure |
Anastrozole
n=337 participants at risk
Patients receive oral anastrozole once daily on days 1-28
|
Anastrozole & Fulvestrant
n=348 participants at risk
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
19.0%
64/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
23.0%
80/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Constipation
|
26.4%
89/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
31.6%
110/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
64/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
20.7%
72/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
13.6%
46/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.5%
47/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.7%
26/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
4.3%
15/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Nausea
|
33.8%
114/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
34.2%
119/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
12.2%
41/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.5%
47/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Gastrointestinal disorders
Vomiting
|
17.8%
60/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
16.4%
57/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Edema: limb
|
21.4%
72/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
25.6%
89/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.2%
203/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
63.2%
220/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
7.7%
26/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.0%
21/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Injection site reaction/extravasation changes
|
1.2%
4/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.8%
48/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Pain - Chest/thorax NOS
|
8.0%
27/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
14.9%
52/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Pain-Other
|
24.6%
83/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
31.0%
108/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
General disorders
Rigors/chills
|
8.3%
28/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.7%
20/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
5.3%
18/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.3%
22/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Infections and infestations
Infection-Other
|
11.9%
40/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.5%
47/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.7%
36/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
7.2%
25/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
AST, SGOT
|
15.4%
52/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
12.4%
43/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Alkaline phosphatase
|
10.7%
36/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.2%
46/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Creatinine
|
10.7%
36/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.5%
47/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Leukocytes (total WBC)
|
11.0%
37/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
9.8%
34/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Lymphopenia
|
3.0%
10/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.3%
22/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Platelets
|
4.2%
14/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
7.5%
26/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Weight gain
|
9.2%
31/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
12.1%
42/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Investigations
Weight loss
|
7.1%
24/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.0%
21/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.3%
18/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.2%
18/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
78/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
21.3%
74/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.9%
20/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
7.2%
25/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.9%
20/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
7.2%
25/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
21.7%
73/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
27.3%
95/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
1.8%
6/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.2%
18/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.3%
11/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
7.2%
25/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.0%
27/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
8.9%
31/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
7.7%
26/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
8.3%
29/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
3.6%
12/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.2%
18/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
40.1%
135/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
37.4%
130/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
27.6%
93/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
32.5%
113/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
10.4%
35/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
13.5%
47/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
45.1%
152/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
44.0%
153/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
23.7%
80/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
22.7%
79/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Dizziness
|
17.5%
59/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
18.7%
65/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Neuropathy: motor
|
8.0%
27/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.0%
21/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Neuropathy: sensory
|
20.5%
69/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
26.4%
92/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Nervous system disorders
Pain - Head/headache
|
19.6%
66/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
23.3%
81/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Confusion
|
5.6%
19/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
4.3%
15/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Insomnia
|
28.2%
95/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
27.9%
97/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Mood alteration - agitation
|
3.9%
13/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.2%
18/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
17.2%
58/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
16.7%
58/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Psychiatric disorders
Mood alteration - depression
|
18.7%
63/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
22.7%
79/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.4%
8/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.7%
20/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Reproductive system and breast disorders
Pain - Pelvis
|
5.0%
17/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.9%
24/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.5%
22/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.9%
24/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.4%
8/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.5%
19/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.0%
91/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
26.4%
92/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
28.5%
96/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
29.3%
102/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
3.6%
12/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
5.5%
19/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
3.3%
11/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
6.6%
23/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.0%
27/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
12.9%
45/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.4%
45/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
17.5%
61/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
15.7%
53/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
17.8%
62/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Vascular disorders
Hot flashes/flushes
|
45.7%
154/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
54.3%
189/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
|
Vascular disorders
Hypertension
|
14.5%
49/337 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
15.2%
53/348 • Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
|
Additional Information
Breast Committee Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place