Trial Outcomes & Findings for Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00096447)
NCT ID: NCT00096447
Last Updated: 2019-07-24
Results Overview
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.
Results posted on
2019-07-24
Participant Flow
The study was activated on 11/1/2004 and closed to accrual on 9/26/2005.
Participant milestones
| Measure |
GW572016
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
GW572016
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Age, Customized
30-39 years
|
2 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
3 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
13 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent
|
30 participants
n=5 Participants
|
|
Histologic Type
Adenocarcinoma, Unspecified
|
2 participants
n=5 Participants
|
|
Histologic Type
Clear Cell Carcinoma
|
3 participants
n=5 Participants
|
|
Histologic Type
Endometrioid Adenocarcinoma
|
16 participants
n=5 Participants
|
|
Histologic Type
Mixed Epithelial Carcinoma
|
2 participants
n=5 Participants
|
|
Histologic Type
Serous Adenocarcinoma
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.Population: Eligible and treated patients.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Percentage of Patients With Progression-free Survival > 6 Months
|
10 percentage of participants
Interval 2.3 to 23.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle during treatment and 30 days after the last cycle of therapy.Population: Eligible and evaluable patients
The frequency and severity of all toxicities are tabulated.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=30 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=30 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=30 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=30 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Leukopenia
|
29 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Thrombocytopenia
|
28 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Anemia
|
11 Participants
|
8 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Cardiovascular
|
28 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Constitutional
|
13 Participants
|
10 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Dermatologic
|
22 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Gastrointestinal
|
5 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Genitourinary/renal
|
29 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Hemorrhage
|
29 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Lymphatics
|
29 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Musculoskeletal
|
27 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Metabolic
|
20 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Neuropathy
|
29 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Other hematologic
|
27 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Ocular
|
26 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Pain
|
25 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
Pulmonary
|
27 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.Population: Eligible and treated patients.
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. 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; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Percentage of Patients With Tumor Response
|
3.3 percentage of participants
Interval 0.2 to 14.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and evaluable patients
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Duration of Progression-free Survival
|
1.82 months
Interval 1.41 to 3.48
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years.Population: Eligible and treated patients.
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Overall Survival
|
7.33 Months
Interval 3.94 to 15.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and evaluable
Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Prognostic Factors (Performance Status)
Performance status 0
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Factors (Performance Status)
Performance status 1
|
11 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and evaluable
G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Outcome measures
| Measure |
GW572016
n=30 Participants
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Prognostic Factor (Histologic Grade)
Grade 1
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Factor (Histologic Grade)
Grade 2
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Factor (Histologic Grade)
Grade 3
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Factor (Histologic Grade)
Not graded
|
7 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
GW572016
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GW572016
n=30 participants at risk
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Obstruction, Gi - Jejunum
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
GW572016
n=30 participants at risk
1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Immune system disorders
Rhinitis
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Platelets
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukocytes
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.0%
21/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypertension
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Valvular Heart Disease
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypotension
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Vascular disorders
Inr
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Vascular disorders
Ptt
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Sweating
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Fever
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Weight Loss
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Rigors/Chills
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
66.7%
20/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Insomnia
|
20.0%
6/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
8/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hot Flashes
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Diabetes
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Heartburn
|
13.3%
4/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Distention
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Alteration
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
8/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
15/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dehydration
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
20.0%
6/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
15/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
18/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Infection - Other
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Ungual (Nails)
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Viscera
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Limb
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ast
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Proteinuria
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Creatinine
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alt
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
20.0%
6/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bilirubin
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.3%
7/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.3%
4/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Depression
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Ataxia
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Memory Impairment
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Sensory
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Motor
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Eye disorders
Glaucoma
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Eye disorders
Dry Eye
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Eye disorders
Blurred Vision
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Pelvis
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Vagina
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest /Thorax Nos
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest Wall
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Head/Headache
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Extremity-Limb
|
13.3%
4/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Back
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Joint
|
16.7%
5/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Stomach
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Oral Cavity
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
16.7%
5/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Lip
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Middle Ear
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Tumor
|
10.0%
3/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Muscle
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
9/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Retention
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Fistula, Gu - Genital Tract-Female
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Frequency
|
6.7%
2/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
3.3%
1/30 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are all Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60