Trial Outcomes & Findings for Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer (NCT NCT00113373)
NCT ID: NCT00113373
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
28 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 measurable disease every other cycle for the first 6 months
Results posted on
2019-07-24
Participant Flow
The study was activated on 5/2/2005 and closed to accrual on 5/1/2006.
Participant milestones
| Measure |
Lapatinib
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Lapatinib
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Ineligible: wrong primary
|
1
|
|
Overall Study
Ineligible: second primary
|
1
|
|
Overall Study
Never Treated
|
1
|
Baseline Characteristics
Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Age, Customized
40-49 years
|
3 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
4 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
12 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent
|
25 participants
n=5 Participants
|
|
Histologic Type
Endometrioid Adenocarcinoma
|
3 participants
n=5 Participants
|
|
Histologic Type
Undifferentiated Carcinoma
|
2 participants
n=5 Participants
|
|
Histologic Type
Serous Adenocarcinoma
|
20 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 measurable disease every other cycle for the first 6 monthsPopulation: 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 |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS) > 6 Months
|
8.0 percentage of participants
Interval 1.4 to 23.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatmentPopulation: Eligible and evaluable
Outcome measures
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=25 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=25 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=25 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=25 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Leukopenia
|
23 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Thrombocytopenia
|
24 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Anemia
|
12 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Other hematologic
|
24 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Hearing
|
21 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Constitutional
|
12 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Dermatologic
|
15 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Gastrointestinal
|
5 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Hemorrhage
|
23 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Infection
|
24 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Lymphatics
|
24 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Musculoskeletal
|
22 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Metabolic
|
13 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Neuropathy
|
21 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Ocular
|
24 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Pain
|
17 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Pulmonary
|
23 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, every other cycle for 6 months and then every 6 months for up to 5 yearsPopulation: Eligible and Treated Patients
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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
|
|---|---|---|---|---|---|
|
Tumor Response
|
0 percentage of participants
Interval 0.0 to 8.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for 6 months and then every 6 months for up to 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 |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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
|
1.77 months
Interval 1.28 to 1.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From entry into the study to death or the date of last contact, assessed up to 5 yearsPopulation: 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 |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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
|
10.5 months
Interval 3.4 to 17.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and evaluable patients
Patients who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Patients who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Patients who had disease progression beyond12 months of ending their last platinum regimen were also considered platinum sensitive.
Outcome measures
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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 Variable: Platinum Sensitivity
Platinum Sensitive
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Variable: Platinum Sensitivity
Platinum Resistant
|
16 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
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 Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Outcome measures
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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 Variables: Performance Status
Performance Status 0
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Variables: Performance Status
Performance Status 1
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Variables: Performance Status
Performance Status 2
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and evaluable patients
Number of patients with Clear Cell Carcinoma or Mucinous Carcinoma
Outcome measures
| Measure |
Lapatinib
n=25 Participants
1500 mg of lapatinib 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 Variable: Cellular Histology
Clear Cell Carcinoma
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Prognostic Variable: Cellular Histology
Mucinous Carcinoma
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Lapatinib
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib
n=25 participants at risk
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
12.0%
3/25 • 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
Acne
|
4.0%
1/25 • 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 - Death Nos
|
4.0%
1/25 • 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
Ileus
|
8.0%
2/25 • 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 - Small Bowel Nos
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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 |
Lapatinib
n=25 participants at risk
1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
16.0%
4/25 • 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
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
Lymphopenia
|
8.0%
2/25 • 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
|
60.0%
15/25 • 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
|
8.0%
2/25 • 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
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
|
52.0%
13/25 • 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 - Death Nos
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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)
|
16.0%
4/25 • 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
Acne
|
20.0%
5/25 • 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
|
20.0%
5/25 • 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
Dry Skin
|
16.0%
4/25 • 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
Pruritus
|
8.0%
2/25 • 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
Hand-Foot
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
Hypothyroidism
|
4.0%
1/25 • 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
Esophagitis
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Ascites
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
16.0%
4/25 • 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
|
4.0%
1/25 • 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
Dry Mouth
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Colitis
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
|
28.0%
7/25 • 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
|
20.0%
5/25 • 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
|
8.0%
2/25 • 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
|
32.0%
8/25 • 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
|
64.0%
16/25 • 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
|
72.0%
18/25 • 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
|
8.0%
2/25 • 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 - Rectum
|
4.0%
1/25 • 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/Pulmonary - Nose
|
12.0%
3/25 • 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 - Bladder
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Colitis, Infectious (Eg.C. Difficile)
|
4.0%
1/25 • 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: Urinary Tract Nos
|
4.0%
1/25 • 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)
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
|
12.0%
3/25 • 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
Cholesterol,serum High
|
4.0%
1/25 • 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
|
20.0%
5/25 • 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
|
16.0%
4/25 • 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
|
12.0%
3/25 • 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
|
12.0%
3/25 • 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
|
4.0%
1/25 • 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
|
24.0%
6/25 • 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
Hyperuricemia
|
4.0%
1/25 • 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
Bicarbonate, Serum-Low
|
4.0%
1/25 • 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
|
12.0%
3/25 • 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
Hyperkalemia
|
4.0%
1/25 • 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
|
36.0%
9/25 • 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
|
16.0%
4/25 • 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
Hypoglycemia
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
16.0%
4/25 • 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
Soft Tissue Necrosis - Abdomen
|
4.0%
1/25 • 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
Osteoporosis
|
4.0%
1/25 • 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
Joint-Function
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
28.0%
7/25 • 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 - Anxiety
|
4.0%
1/25 • 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
Confusion
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
20.0%
5/25 • 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
Flashing Lights/Floaters
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
16.0%
4/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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: Bladder
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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
|
4.0%
1/25 • 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
|
40.0%
10/25 • 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
|
8.0%
2/25 • 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
|
12.0%
3/25 • 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
|
28.0%
7/25 • 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
Bladder Spasm
|
4.0%
1/25 • 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
|
8.0%
2/25 • 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 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