Trial Outcomes & Findings for Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer (NCT NCT00112489)
NCT ID: NCT00112489
Last Updated: 2018-09-25
Results Overview
Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
During study treatment and up to 30 days after stopping study treatment
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
Paclitaxel Followed by Carboplatin
Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Paclitaxel Followed by Carboplatin
Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Refused further treatment
|
8
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
2
|
|
Overall Study
Other, Not Specified
|
9
|
|
Overall Study
Patient never treated
|
2
|
|
Overall Study
Ineligible
|
7
|
Baseline Characteristics
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel Followed by Carboplatin
n=46 Participants
Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
Age at Study Entry
|
65.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During study treatment and up to 30 days after stopping study treatmentPopulation: Eligible and Evaluable patients
Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Outcome measures
| Measure |
Grade 0
n=46 Participants
Number of patients who did not experience the specified AE
|
Grade 1 (CTCAE v 3.0)
n=46 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=46 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=46 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=46 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v.3.0)
n=46 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Nature and Degree of Toxicity
Pain
|
35 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Leukopenia
|
2 Participants
|
4 Participants
|
20 Participants
|
19 Participants
|
1 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Neutropenia
|
1 Participants
|
3 Participants
|
3 Participants
|
19 Participants
|
20 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Thrombocytopenia
|
17 Participants
|
19 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Anemia
|
4 Participants
|
10 Participants
|
27 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Other hematologic
|
43 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Allergy
|
40 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Auditory
|
43 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Cardiovascular
|
39 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Coagulation
|
45 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Constitutional
|
33 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Fatigue
|
9 Participants
|
14 Participants
|
19 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Alopecia
|
8 Participants
|
7 Participants
|
31 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Dermatologic
|
36 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Endocrine
|
44 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Gastrointestinal
|
18 Participants
|
12 Participants
|
14 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Nausea
|
17 Participants
|
20 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Vomiting
|
35 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Diarrhea
|
35 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Stomatitis
|
35 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Genitourinary/renal
|
45 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Hemorrhage
|
43 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Hepatic
|
45 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Febrile neutropenia
|
45 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Metabolic
|
23 Participants
|
18 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Creatinine
|
44 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Musculoskeletal
|
41 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Neurologic
|
40 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Neuromotor
|
44 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Sensory neuropathy
|
14 Participants
|
15 Participants
|
12 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Ocular/visual
|
43 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Myalgia
|
35 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Arthralgia
|
36 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Nature and Degree of Toxicity
Pulmonary
|
37 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Response was measured every other cycle (q 6 weeks) until disease progression is documented.Population: Total eligible and treated participants
Primary outcome measured according to RECIST v1.0 Best Response: 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 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. 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. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required 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 |
Grade 0
n=46 Participants
Number of patients who did not experience the specified AE
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v.3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Complete Response
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Partial Response
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Stable Disease
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Disease Progression
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Indeterminate
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Paclitaxel Followed by Carboplatin
Serious events: 11 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel Followed by Carboplatin
n=46 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Vascular disorders
PTT
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
General disorders
Fatigue
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Cardiac disorders
S/n arrhythmia: atrial fibrillation
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Cardiac disorders
Hypotension
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
General disorders
Death, no ctcae term - death nos
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
General disorders
Death, no ctcae term - disease progression
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Dehydration
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Distention
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Obstruction, gi - colon
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Blood and lymphatic system disorders
Leukocytes
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Blood and lymphatic system disorders
Neutrophils
|
4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Infections and infestations
Inf w/nml or gr 1 or 2 anc: urinary tract
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Infections and infestations
Inf unknown anc: bladder (urinary)
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Infections and infestations
Inf unknown anc: urinary tract nos
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - extremity-lower
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Musculoskeletal and connective tissue disorders
muscle weakness - extremity-upper
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Metabolism and nutrition disorders
Bilirubin
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Nervous system disorders
Confusion
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
General disorders
Pain: abdominal pain nos
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
|
Other adverse events
| Measure |
Paclitaxel Followed by Carboplatin
n=46 participants at risk
Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
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Metabolism and nutrition disorders
Metabolic
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13.0%
6/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Musculoskeletal and connective tissue disorders
Musculoskeletal
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6.5%
3/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Nervous system disorders
Neurologic
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13.0%
6/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Leukopenia
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87.0%
40/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Neutropenia
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93.5%
43/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Thrombocytopenia
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21.7%
10/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Anemia
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69.6%
32/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Other Hematologic
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6.5%
3/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Immune system disorders
Allergy
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6.5%
3/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Ear and labyrinth disorders
Auditory
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6.5%
3/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Cardiac disorders
Cardiovascular
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8.7%
4/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Vascular disorders
Coagulation
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2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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General disorders
Constitutional
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10.9%
5/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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General disorders
Fatigue
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52.2%
24/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Skin and subcutaneous tissue disorders
Alopecia
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67.4%
31/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Skin and subcutaneous tissue disorders
Dermatologic
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4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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General disorders
Death
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4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Gastrointestinal disorders
Other, Gastrointestinal
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34.8%
16/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Gastrointestinal disorders
Nausea
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19.6%
9/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Gastrointestinal disorders
Vomiting
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8.7%
4/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Gastrointestinal disorders
Diarrhea
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6.5%
3/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Hemorrhage
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4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Blood and lymphatic system disorders
Febrile Neutropenia
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2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Nervous system disorders
Neuromotor
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4.3%
2/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Nervous system disorders
Sensory Neuropathy
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39.1%
18/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Eye disorders
Ocular/Visual
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2.2%
1/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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General disorders
Pain
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17.4%
8/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Musculoskeletal and connective tissue disorders
Myalgia
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17.4%
8/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Musculoskeletal and connective tissue disorders
Arthralgia
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13.0%
6/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Respiratory, thoracic and mediastinal disorders
Pulmonary
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8.7%
4/46 • During active treatment and up to 30 days after stopping the study treatment.
Treated \& eligible patients. Due to the methods in which Adverse Events(AEs) were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore it is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse \& are restricted to those thought to be treatment related.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place