Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
What was measured
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)
Analysis 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.
Groups in this outcome
Arm I Anastrozole
Patients receive oral anastrozole once daily on days 1-28
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm I Anastrozole
337
Arm II Anastrozole and Fulvestrant
348
Reported measurements
ALT, SGPT (serum glutamic pyruvic transaminase)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
AST, SGOT
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Albumin, serum-low (hypoalbuminemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Alkaline phosphatase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Bilirubin (hyperbilirubinemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
CNS cerebrovascular ischemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Calcium, serum-high (hypercalcemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Cataract
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Confusion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
2
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Dyspnea (shortness of breath)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Edema: limb
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
7
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
9
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Fracture
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Glucose, serum-high (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Hemolysis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Hot flashes/flushes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
2
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
7
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
2
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Infection with unknown ANC - Urinary tract NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Joint-effusion
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Memory impairment
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Mood alteration - agitation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Mood alteration - anxiety
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Mood alteration - depression
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Mucositis/stomatitis (functional/symp) - Pharynx
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Muscle weakness, not d/t neuropathy - body/general
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Neurology-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Pain - Abdomen NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Pain - Back
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
5
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
7
Not reported
Not reported
Not reported
Not reported
Pain - Bone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Pain - Breast
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Pain - Buttock
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Pain - Chest wall
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Pain - Chest/thorax NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Pain - Extremity-limb
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Pain - Head/headache
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Pain - Joint
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
5
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
7
Not reported
Not reported
Not reported
Not reported
Pain - Muscle
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Pain - Neck
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Pain - Pelvis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
3
Not reported
Not reported
Not reported
Not reported
Pain-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
2
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Platelets
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
2
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Rash/desquamation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Sodium, serum-low (hyponatremia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Speech impairment (e.g., dysphasia or aphasia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
1
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
0
Not reported
Not reported
Not reported
Not reported
Sudden death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Syncope (fainting)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Thrombosis/embolism (vascular access-related)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Thrombosis/thrombus/embolism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
6
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
7
Not reported
Not reported
Not reported
Not reported
Tinnitus
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Tumor flare
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Urticaria (hives, welts, wheals)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
3
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
2
Not reported
Not reported
Not reported
Not reported
Weight gain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I Anastrozole
0
Not reported
Not reported
Not reported
Not reported
Arm II Anastrozole and Fulvestrant
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
ALT, SGPT (serum glutamic pyruvic transaminase)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
AST, SGOT
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Albumin, serum-low (hypoalbuminemia)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Alkaline phosphatase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Anorexia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Bilirubin (hyperbilirubinemia)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
CNS cerebrovascular ischemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Calcium, serum-high (hypercalcemia)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Cataract
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Confusion
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Constipation
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Dehydration
denoms
counts
group Id
OG000
value
337
group Id
OG001
value
348
units
Participants
description
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)
groups
description
Patients receive oral anastrozole once daily on days 1-28
id
OG000
title
Arm I Anastrozole
description
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.
id
OG001
title
Arm II Anastrozole and Fulvestrant
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
title
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Triangle