Trial Outcomes & Findings for Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00114166)
NCT ID: NCT00114166
Last Updated: 2018-07-24
Results Overview
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is 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. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
Results posted on
2018-07-24
Participant Flow
Regimen 1 (Topotecan 1.25 mg/m2) recruitment ended early due to lack of interest by institutions.
Participant milestones
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2 )
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
66
|
|
Overall Study
COMPLETED
|
15
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2 )
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Overall Study
Wrong primary
|
0
|
1
|
Baseline Characteristics
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
n=15 Participants
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2)
n=65 Participants
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
3 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Customized
70-79 years
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Customized
> 79 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
65 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Cell Type
Clear Cell Carcinoma
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Cell Type
Undifferentiated Carcinoma
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
13 participants
n=99 Participants
|
50 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Cell Type
Other Carcinoma
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawalPopulation: Eligible and evaluable participants
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is 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. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Outcome measures
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
n=15 Participants
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2)
n=65 Participants
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Objective Tumor Response
Partial Response
|
4 Participants
|
8 Participants
|
|
Objective Tumor Response
Stable Disease
|
8 Participants
|
32 Participants
|
|
Objective Tumor Response
Increase Disease
|
2 Participants
|
21 Participants
|
|
Objective Tumor Response
Indeterminate
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-upPopulation: Eligible and treated patients
Outcome measures
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
n=15 Participants
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2)
n=65 Participants
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Leukopenia
|
10 Participants
|
6 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Thrombocytopenia
|
7 Participants
|
6 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Neutropenia
|
14 Participants
|
18 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Anemia
|
5 Participants
|
9 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Nausea/vomiting
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Other Gastrointestinal
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Neurologic
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Constitutional
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Cardiovascular
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Infection
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Musculoskeletal
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Pulmonary
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Pain
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: study entry through end of study treatment, up to 5 yearsPopulation: Eligible and evaluable participants
Outcome measures
| Measure |
Regimen I (Topotecan 1.25 mg/m2)
n=15 Participants
Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II (Topotecan 4.0 mg/m2)
n=65 Participants
Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Reason Off Study Therapy
Disease Progression
|
9 Participants
|
47 Participants
|
|
Reason Off Study Therapy
Refused further treatment
|
3 Participants
|
7 Participants
|
|
Reason Off Study Therapy
Toxicity as permitted
|
3 Participants
|
2 Participants
|
|
Reason Off Study Therapy
Other
|
0 Participants
|
9 Participants
|
Adverse Events
Regimen I
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Regimen II
Serious events: 10 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen I
n=15 participants at risk
Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II
n=65 participants at risk
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Obstruction, Gi - Cecum
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bronchus
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Mood Alteration - Depression
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Back
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Abdominal Pain Nos
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
Other adverse events
| Measure |
Regimen I
n=15 participants at risk
Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
|
Regimen II
n=65 participants at risk
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
15.4%
10/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Immune system disorders
Rhinitis
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Neutrophils
|
60.0%
9/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
67.7%
44/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Platelets
|
53.3%
8/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
58.5%
38/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Leukocytes
|
53.3%
8/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
72.3%
47/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
53.3%
8/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
89.2%
58/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
10.8%
7/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Inr
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Ptt
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Sweating
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Weight Gain
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Fever
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
13.8%
9/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Weight Loss
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Rigors/Chills
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Fatigue
|
53.3%
8/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
70.8%
46/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Insomnia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
21.5%
14/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
33.3%
5/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
29.2%
19/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Endocrine disorders
Diabetes
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Heartburn
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
12.3%
8/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Distention
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Taste Alteration
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
10.8%
7/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
18.5%
12/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Anorexia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
24.6%
16/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
44.6%
29/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
60.0%
39/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Petechiae
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Infection - Other
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
16.9%
11/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Ast
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
13.8%
9/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Gfr
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Creatinine
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
9.2%
6/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Alt
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
12.3%
8/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
12.3%
8/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Bilirubin
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
9.2%
6/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.7%
4/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
30.8%
20/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
16.9%
11/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
5/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
15.4%
10/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
9.2%
6/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Involuntary Movement
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Mood Alteration - Depression
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
12.3%
8/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
10.8%
7/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Mood Alteration - Agitation
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Speech Impairment
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Confusion
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
12.3%
8/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Neuropathy-Sensory
|
20.0%
3/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
40.0%
26/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Nervous system disorders
Neuropathy-Motor
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Eye disorders
Watery Eye
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Eye disorders
Blurred Vision
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain - Other
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
6.2%
4/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Urethra
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Pelvis
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Chest /Thorax Nos
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Chest Wall
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Head/Headache
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
16.9%
11/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Neck
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Extremity-Limb
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
15.4%
10/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Back
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
13.8%
9/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Joint
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
7.7%
5/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Bone
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Lymph Node
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Kidney
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
0.00%
0/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Pain Nos
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Oral Cavity
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Abdominal Pain Nos
|
20.0%
3/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
24.6%
16/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Tumor
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
General disorders
Pain: Muscle
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
20.0%
13/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
32.3%
21/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
4.6%
3/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
3.1%
2/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Renal and urinary disorders
Urinary Frequency
|
13.3%
2/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
6.7%
1/15 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
1.5%
1/65 • All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
|
Additional Information
Jessalyn Reboy
NRG Oncology, Statistics and Data Management Center - Buffalo Office
Phone: 716-845-7738
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place