Trial Outcomes & Findings for Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT NCT00110019)
NCT ID: NCT00110019
Last Updated: 2015-10-19
Results Overview
Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
823 participants
Primary outcome timeframe
Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.
Results posted on
2015-10-19
Participant Flow
This study was activated on June 23, 2005, and terminated on April 22, 2008 with the final accrual of 823 patients. Most of patients were accrued through Eastern Cooperative Oncology Group (ECOG), Cancer and Leukemia Group B (CALGB), and Southwest Oncology Group (SWOG). Other Clinical Trials Cooperative Groups also participated.
Participant milestones
| Measure |
Arm I (Carboplatin+Paclitaxel+Sorafenib)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin+Paclitaxel)
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Overall Study
STARTED
|
410
|
413
|
|
Overall Study
Eligible
|
395
|
398
|
|
Overall Study
Treated
|
393
|
397
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
406
|
413
|
Reasons for withdrawal
| Measure |
Arm I (Carboplatin+Paclitaxel+Sorafenib)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin+Paclitaxel)
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
253
|
285
|
|
Overall Study
Adverse Event
|
61
|
40
|
|
Overall Study
Death
|
13
|
15
|
|
Overall Study
Withdrawal by Subject
|
21
|
9
|
|
Overall Study
alternative therapy
|
5
|
1
|
|
Overall Study
complicating disease
|
1
|
1
|
|
Overall Study
symptom deterioration
|
13
|
16
|
|
Overall Study
Not start protocol therapy
|
17
|
16
|
|
Overall Study
other reasons
|
22
|
30
|
Baseline Characteristics
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Carboplatin+Paclitaxel+Sorafenib)
n=410 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin+Paclitaxel)
n=413 Participants
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
Total
n=823 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
58 years
n=4 Participants
|
59 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=93 Participants
|
162 Participants
n=4 Participants
|
302 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
270 Participants
n=93 Participants
|
251 Participants
n=4 Participants
|
521 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.Population: Intention-to-treat population, n=823
Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Outcome measures
| Measure |
Arm I (Carboplatin + Paclitaxel + Sorafenib)
n=410 Participants
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin + Paclitaxel+Placebo)
n=413 Participants
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Overall Survival
|
11.1 months
Interval 10.3 to 12.3
|
11.3 months
Interval 9.8 to 12.2
|
SECONDARY outcome
Timeframe: Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.Population: Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis
Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Outcome measures
| Measure |
Arm I (Carboplatin + Paclitaxel + Sorafenib)
n=409 Participants
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin + Paclitaxel+Placebo)
n=412 Participants
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Progression-free Survival
|
4.9 months
Interval 4.5 to 5.6
|
4.2 months
Interval 3.4 to 4.7
|
SECONDARY outcome
Timeframe: Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.Population: Intention-to-treat population, n=823
Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
Arm I (Carboplatin + Paclitaxel + Sorafenib)
n=410 Participants
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin + Paclitaxel+Placebo)
n=413 Participants
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Objective Response (Complete and Partial Response) Rate
|
0.205 proportion
Interval 0.167 to 0.247
|
0.182 proportion
Interval 0.146 to 0.222
|
Adverse Events
Arm I (Carboplatin + Paclitaxel + Sorafenib)
Serious events: 332 serious events
Other events: 385 other events
Deaths: 0 deaths
Arm II (Carboplatin + Paclitaxel+Placebo)
Serious events: 311 serious events
Other events: 384 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Carboplatin + Paclitaxel + Sorafenib)
n=393 participants at risk
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin + Paclitaxel+Placebo)
n=397 participants at risk
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Infections and infestations
Infection Gr002 neut, lung
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, pharynx
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ulcer, duodenum
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
13/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.8%
11/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorder-other
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hematoma
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
CNS, hemorrhage
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, hemorrhage NOS
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colon, hemorrhage
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Duodenum, hemorrhage
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Lower GI, hemorrhage NOS
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Stomach, hemorrhage
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Kidney, hemorrhage
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hemorrhage-other
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Colitis, infectious (e.g. C.diff)
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.1%
24/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.3%
17/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, anal/perianal
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, bladder
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, bronchus
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, catheter relate
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, lung
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, oral cavity
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, pharynx
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, skin
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, upper airway
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, urinary tract
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, catheter
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, colon
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, foreign body
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Obstruction, small bowel NOS
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Perforation, colon
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
7.4%
29/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.8%
15/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ileus
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) stomach
|
1.3%
5/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
4.1%
16/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.8%
11/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Death - multiorgan failure
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Death - sudden death
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hot flashes
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.3%
9/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.8%
19/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Immune system disorders
Allergic reaction
|
5.1%
20/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.8%
11/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Ear and labyrinth disorders
Otitis, middle ear
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
7.6%
30/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.1%
28/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Leukopenia
|
27.5%
108/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
22.9%
91/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.3%
17/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Neutropenia
|
48.9%
192/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
49.1%
195/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Thrombocytopenia
|
23.4%
92/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
8.8%
35/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial flutter
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
PVCs
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac-ischemia
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
4.6%
18/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.3%
5/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
2.8%
11/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.3%
5/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
cardiac-other
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
16.0%
63/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
14.1%
56/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
activated partial thromboplastin time (PTT)
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.3%
13/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.8%
58/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.0%
8/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
12.0%
47/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, skin
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.0%
4/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, soft tissue
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, urinary tract
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, wound
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC lung
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC mucosa
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Opportunistic infection
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr304 neut, blood
|
2.3%
9/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.3%
9/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr002 neut, blood
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC blood
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Infections and infestations
Infection- other
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.0%
4/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
5/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
ALT, SGPT
|
1.3%
5/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Serum amylase increased
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
AST, SGOT
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
GGT increased
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
17/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.8%
19/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.5%
6/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
12/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.8%
11/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Metabolic/Laboratory-other
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle
|
1.3%
5/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.8%
7/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Ataxia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Cognitive disturbance
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.0%
8/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Agitation
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy- motor
|
3.1%
12/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.5%
10/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy- sensory
|
20.6%
81/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
14.9%
59/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Personality
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Eye disorders
Cataract
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Eye disorders
Retinal detachment
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Eye disorders
Vision blurred
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Eye disorders
Vision photophobia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
2.8%
11/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.76%
3/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac/heart, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Chest/thoracic pain NOS
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity limb, pain
|
1.5%
6/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
3.6%
14/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.5%
14/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Lymph node, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
4.6%
18/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
5.5%
22/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathic, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Pain NOS
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Pericardium, pain
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleura, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Pain-other
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
5/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.8%
7/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.76%
3/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.00%
0/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal failure
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.5%
6/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.0%
4/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.0%
8/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.51%
2/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.25%
1/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Lipase increased
|
3.6%
14/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.5%
6/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.25%
1/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
0.50%
2/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.3%
9/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm I (Carboplatin + Paclitaxel + Sorafenib)
n=393 participants at risk
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
|
Arm II (Carboplatin + Paclitaxel+Placebo)
n=397 participants at risk
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
48.6%
191/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
49.1%
195/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Leukopenia
|
34.4%
135/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
36.8%
146/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
9.7%
38/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.3%
29/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Neutropenia
|
25.7%
101/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
29.5%
117/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Thrombocytopenia
|
46.3%
182/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
33.0%
131/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
22.1%
87/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
9.6%
38/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
79.1%
311/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
74.6%
296/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
4.8%
19/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
6.3%
25/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
12.0%
47/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
9.8%
39/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
8.7%
34/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
5.3%
21/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Sweating
|
5.9%
23/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.0%
12/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
15.8%
62/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
6.3%
25/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
38/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
2.5%
10/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.0%
12/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.4%
202/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
52.6%
209/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
28.0%
110/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
14.9%
59/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.4%
198/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
26.4%
105/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
30.3%
119/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.1%
28/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
5.1%
20/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.8%
7/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
34.9%
137/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
29.7%
118/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
25.7%
101/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
21.7%
86/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
23/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
5.0%
20/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
50.9%
200/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
28.5%
113/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
9.2%
36/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
8.8%
35/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) stomach
|
21.4%
84/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
11.1%
44/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
52.4%
206/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
57.9%
230/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Taste disturbance
|
14.5%
57/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
13.6%
54/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
104/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
29.5%
117/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
1.3%
5/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
8.9%
35/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.8%
31/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.2%
36/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
6.8%
27/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
11.7%
46/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.3%
29/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase (ALT, SGPT)
|
12.2%
48/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
8.3%
33/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase (AST, SGOT)
|
14.2%
56/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.3%
29/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.8%
58/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
11.1%
44/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Lipase increased
|
6.9%
27/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.5%
14/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.4%
33/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
7.3%
29/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
49/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
5.0%
20/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
51/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
9.3%
37/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-other
|
6.6%
26/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
3.5%
14/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
13.2%
52/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
11.3%
45/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
66.7%
262/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
66.8%
265/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
7.6%
30/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
5.3%
21/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
5.9%
23/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.8%
19/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
11.7%
46/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
8.6%
34/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
39.9%
157/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
38.0%
151/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
40.2%
158/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
45.8%
182/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
22/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.5%
18/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.5%
65/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
13.6%
54/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.4%
37/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
4.3%
17/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
5.3%
21/393 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
6.5%
26/397 • assessed at the end of each cycle (1 cycle = 3 weeks) while on study and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60