Trial Outcomes & Findings for Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer (NCT NCT00050960)
NCT ID: NCT00050960
Last Updated: 2012-07-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
612 participants
Primary outcome timeframe
From date of randomization to date of death
Results posted on
2012-07-13
Participant Flow
Participant milestones
| Measure |
Bexarotene With Carboplatin and Paclitaxel
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
306
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
302
|
304
|
Reasons for withdrawal
| Measure |
Bexarotene With Carboplatin and Paclitaxel
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
137
|
93
|
|
Overall Study
Stable Disease
|
19
|
48
|
|
Overall Study
Partial Response
|
14
|
19
|
|
Overall Study
Complete Response
|
0
|
2
|
|
Overall Study
Adverse Event
|
62
|
61
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
23
|
18
|
|
Overall Study
Administrative
|
31
|
46
|
|
Overall Study
Non-compliance
|
3
|
1
|
|
Overall Study
Death
|
13
|
15
|
Baseline Characteristics
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bexarotene With Carboplatin and Paclitaxel
n=306 Participants
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
n=306 Participants
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
Total
n=612 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
166 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
140 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Age Continuous
|
62.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
304 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
601 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
269 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
541 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of deathPopulation: Intent-to-Treat (ITT)
Outcome measures
| Measure |
Bexarotene With Carboplatin and Paclitaxel
n=306 Participants
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
n=306 Participants
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
|---|---|---|
|
Overall Survival
|
8.5 Months
Interval 7.7 to 9.3
|
9.2 Months
Interval 8.3 to 10.5
|
Adverse Events
Bexarotene With Carboplatin and Paclitaxel
Serious events: 256 serious events
Other events: 293 other events
Deaths: 0 deaths
Carboplatin and Paclitaxel
Serious events: 242 serious events
Other events: 295 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bexarotene With Carboplatin and Paclitaxel
n=293 participants at risk
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
n=295 participants at risk
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
74.7%
219/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
72.2%
213/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer Stage IV
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.34%
1/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
19/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.4%
7/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
18/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.7%
11/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.4%
10/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.7%
8/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
8/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
8/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
1.7%
5/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
5/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
14/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.4%
7/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
11/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.1%
9/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
11/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
5/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
9/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.0%
6/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
8/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.0%
6/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
8/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.7%
5/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
5/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.34%
1/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Pyrexia
|
4.1%
12/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.7%
8/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Asthenia
|
3.1%
9/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.4%
4/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Chest pain
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.4%
7/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Fatigue
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Oedema peripheral
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Pain
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Infections and infestations
Pneumonia
|
3.1%
9/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.0%
6/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Infections and infestations
Sepsis
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Convulsion
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Spinal cord compression
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Polyneuropathy
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Psychiatric disorders
Confusional state
|
1.4%
4/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.34%
1/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
3/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.4%
7/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Vascular disorders
Hypotension
|
0.68%
2/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.0%
3/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
Other adverse events
| Measure |
Bexarotene With Carboplatin and Paclitaxel
n=293 participants at risk
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
|
Carboplatin and Paclitaxel
n=295 participants at risk
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.2%
147/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
38.0%
112/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
47.1%
138/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
24.1%
71/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
44/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
14.2%
42/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.6%
31/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
4.1%
12/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.8%
17/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.4%
10/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hypotriglyceridemia
|
57.3%
168/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.0%
6/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.2%
71/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
16.3%
48/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.7%
40/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
7.5%
22/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
11.9%
35/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.9%
26/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.7%
5/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
22/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.7%
8/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
15/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.7%
8/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.5%
16/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.0%
6/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
5.5%
16/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Psychiatric disorders
Insomnia
|
23.9%
70/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
19.0%
56/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Psychiatric disorders
Depression
|
13.3%
39/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
9.2%
27/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Psychiatric disorders
Anxiety
|
10.9%
32/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.5%
31/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Psychiatric disorders
Confusional state
|
8.2%
24/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.4%
7/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
23.5%
69/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
23.7%
70/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Dizziness
|
15.0%
44/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.8%
32/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Headache
|
13.0%
38/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
9.5%
28/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Paraesthesia
|
9.9%
29/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
11.5%
34/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Polyneuropathy
|
9.6%
28/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.5%
31/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Neuropathy
|
8.9%
26/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
6.4%
19/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Nervous system disorders
Dysgeusia
|
5.8%
17/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
7.8%
23/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.3%
74/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
17.6%
52/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
61/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
15.9%
47/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
6.8%
20/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
7.8%
23/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.8%
17/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
5.8%
17/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
20/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.7%
11/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.5%
19/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.1%
9/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.1%
15/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.4%
10/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Vascular disorders
Hypotension
|
6.1%
18/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.4%
10/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Vascular disorders
Flushing
|
5.5%
16/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
3.1%
9/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Nausea
|
50.2%
147/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
47.5%
140/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.9%
108/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
23.1%
68/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
32.8%
96/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
26.4%
78/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
80/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
28.5%
84/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
39/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
6.4%
19/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
19/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
6.4%
19/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
6.5%
19/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
6.1%
18/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
17/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
4.1%
12/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
20/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
2.7%
8/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.2%
147/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
52.2%
154/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
47/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
7.5%
22/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.2%
27/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
6.8%
20/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
11.9%
35/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
24/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
1.7%
5/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Skin and subcutaneous tissue disorders
Skin desquamation
|
5.1%
15/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.6%
78/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
23.1%
68/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.8%
61/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
18.6%
55/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
55/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.8%
32/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
34/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
11.9%
35/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.8%
23/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
5.4%
16/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Fatigue
|
53.2%
156/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
46.4%
137/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Asthenia
|
22.9%
67/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
16.6%
49/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Chest pain
|
15.0%
44/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
19.0%
56/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Oedema peripheral
|
13.3%
39/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
12.9%
38/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Pain
|
9.2%
27/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.2%
30/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
General disorders
Pyrexia
|
15.7%
46/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
15.9%
47/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Investigations
Weight decreased
|
14.0%
41/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
10.2%
30/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Investigations
Blood triglycerides increased
|
9.2%
27/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.00%
0/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
|
Endocrine disorders
Hypothyroidism
|
24.9%
73/293
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
0.68%
2/295
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
|
Additional Information
Eisai, Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place