Trial Outcomes & Findings for Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC (NCT NCT00499109)
NCT ID: NCT00499109
Last Updated: 2014-07-09
Results Overview
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
6 months
Results posted on
2014-07-09
Participant Flow
Participants were registered onto the trial between May 8, 2007 and December 23, 2010. Study sites included Moffitt Cancer Center and 8 other institutions with locations in the United States, Puerto Rico and Germany.
Participant milestones
| Measure |
E. Dual Agent Chemotherapy
Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
|
C. Standard of Care Control Arm
Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
92
|
|
Overall Study
COMPLETED
|
165
|
85
|
|
Overall Study
NOT COMPLETED
|
18
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC
Baseline characteristics by cohort
| Measure |
E. Dual Agent Chemotherapy
n=183 Participants
Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
|
C. Standard of Care Control Arm
n=92 Participants
Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
n=99 Participants
|
62.3 years
n=107 Participants
|
63.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=99 Participants
|
75 participants
n=107 Participants
|
231 participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=99 Participants
|
16 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.
Outcome measures
| Measure |
E. Dual Agent Chemotherapy
n=183 Participants
Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
|
C. Standard of Care Control Arm
n=92 Participants
Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
52 estimated percentage of participants
Interval 45.2 to 59.8
|
56.5 estimated percentage of participants
Interval 47.2 to 67.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants
OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival.
Outcome measures
| Measure |
E. Dual Agent Chemotherapy
n=183 Participants
Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
|
C. Standard of Care Control Arm
n=92 Participants
Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
|
|---|---|---|
|
Overall Survival (OS)
|
46.1 estimated percentage of participants
Interval 39.3 to 54.0
|
46.6 estimated percentage of participants
Interval 37.5 to 58.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All evaluable participants
Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
E. Dual Agent Chemotherapy
n=165 Participants
Experimental Arm E.
Patients received treatment according to gene expression strata with four doublet regimens.
Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.
Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.
High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.
High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
|
C. Standard of Care Control Arm
n=85 Participants
Control Arm C: Gemcitabine and Carboplatin (GCb).
All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
|
|---|---|---|
|
Response Rate (RR)
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Response Rate (RR)
Partial Response (PR)
|
64 participants
|
31 participants
|
Adverse Events
Experimental: E1
Serious events: 21 serious events
Other events: 57 other events
Deaths: 0 deaths
Experimental: E2
Serious events: 12 serious events
Other events: 24 other events
Deaths: 0 deaths
Experimental: E3
Serious events: 16 serious events
Other events: 34 other events
Deaths: 0 deaths
Experimental: E4
Serious events: 20 serious events
Other events: 54 other events
Deaths: 0 deaths
Control: C
Serious events: 32 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: E1
n=64 participants at risk
Docetaxel/Vinorelbine
|
Experimental: E2
n=26 participants at risk
Docetaxel/Carboplatin
|
Experimental: E3
n=37 participants at risk
Gemcitabine/Docetaxel
|
Experimental: E4
n=56 participants at risk
Gemcitabine/Carboplatin
|
Control: C
n=92 participants at risk
Gemcitabine/Carboplatin
|
|---|---|---|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Burn
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Cardiac disorders
Cardiac General - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Psychiatric disorders
Confusion
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Constitutional Symptoms - Other
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 3 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/64 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Death not associated with CTCAE term - Multi-organ failure
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Death not associated with CTCAE term - Sudden death
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Dehydration
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 2 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Dizziness
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.2%
4/64 • Number of events 5 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
8.7%
8/92 • Number of events 10 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Esophagitis
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
General disorders
Febrile neutropenia: fever - unknown origin W/O clinically or microbiologically documented infection
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 2 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
Nervous system disorders
Hemorrhage, CNS
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Hemorrhage, GI - Abdomen NOS
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Hemorrhage/Bleeding - Other
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Cardiac disorders
Hypotension
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils/Lung/pneumonia
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils/Skin/cellulitis
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils/Wound
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Infections and infestations
Infection - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Bronchus
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Wound
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Leukocytes (total WBC)
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 2 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 4 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 4 • Up to 6 months per participant
|
|
General disorders
Neurology - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Neutrophils/granulocytes (ANC/AGC)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Renal and urinary disorders
Obstruction, GU - Ureter
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Pain - Abdomen NOS
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Pain - Back
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Pain - Bone
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Pain - Chest wall
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Pain - Chest/thorax NOS
|
1.6%
1/64 • Number of events 2 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
General disorders
Pain - Extremity-limb
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Platelets
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 4 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 5 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 3 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Somnolence/depressed level of consciousness
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
General disorders
Speech impairment (e.g., dysphasia or aphasia)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Syncope (fainting)
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Vascular disorders
Vascular - Other
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 4 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 5 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
Other adverse events
| Measure |
Experimental: E1
n=64 participants at risk
Docetaxel/Vinorelbine
|
Experimental: E2
n=26 participants at risk
Docetaxel/Carboplatin
|
Experimental: E3
n=37 participants at risk
Gemcitabine/Docetaxel
|
Experimental: E4
n=56 participants at risk
Gemcitabine/Carboplatin
|
Control: C
n=92 participants at risk
Gemcitabine/Carboplatin
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.6%
26/64 • Number of events 28 • Up to 6 months per participant
|
61.5%
16/26 • Number of events 19 • Up to 6 months per participant
|
35.1%
13/37 • Number of events 17 • Up to 6 months per participant
|
55.4%
31/56 • Number of events 34 • Up to 6 months per participant
|
52.2%
48/92 • Number of events 58 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Constipation
|
28.1%
18/64 • Number of events 19 • Up to 6 months per participant
|
26.9%
7/26 • Number of events 7 • Up to 6 months per participant
|
27.0%
10/37 • Number of events 11 • Up to 6 months per participant
|
30.4%
17/56 • Number of events 18 • Up to 6 months per participant
|
33.7%
31/92 • Number of events 36 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Vomiting
|
26.6%
17/64 • Number of events 22 • Up to 6 months per participant
|
42.3%
11/26 • Number of events 14 • Up to 6 months per participant
|
24.3%
9/37 • Number of events 13 • Up to 6 months per participant
|
23.2%
13/56 • Number of events 13 • Up to 6 months per participant
|
81.5%
75/92 • Number of events 98 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
20/64 • Number of events 26 • Up to 6 months per participant
|
46.2%
12/26 • Number of events 16 • Up to 6 months per participant
|
35.1%
13/37 • Number of events 29 • Up to 6 months per participant
|
16.1%
9/56 • Number of events 10 • Up to 6 months per participant
|
13.0%
12/92 • Number of events 14 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Anorexia
|
29.7%
19/64 • Number of events 19 • Up to 6 months per participant
|
23.1%
6/26 • Number of events 9 • Up to 6 months per participant
|
27.0%
10/37 • Number of events 15 • Up to 6 months per participant
|
19.6%
11/56 • Number of events 13 • Up to 6 months per participant
|
17.4%
16/92 • Number of events 16 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
21.9%
14/64 • Number of events 14 • Up to 6 months per participant
|
26.9%
7/26 • Number of events 7 • Up to 6 months per participant
|
29.7%
11/37 • Number of events 11 • Up to 6 months per participant
|
12.5%
7/56 • Number of events 7 • Up to 6 months per participant
|
14.1%
13/92 • Number of events 14 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
21.9%
14/64 • Number of events 16 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
12.5%
8/64 • Number of events 8 • Up to 6 months per participant
|
11.5%
3/26 • Number of events 3 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 2 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 2 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 3 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
9.4%
6/64 • Number of events 6 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 6 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 6 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 2 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
62.5%
40/64 • Number of events 66 • Up to 6 months per participant
|
76.9%
20/26 • Number of events 28 • Up to 6 months per participant
|
75.7%
28/37 • Number of events 37 • Up to 6 months per participant
|
50.0%
28/56 • Number of events 40 • Up to 6 months per participant
|
71.7%
66/92 • Number of events 81 • Up to 6 months per participant
|
|
General disorders
Fever (in the absence of neutropenia)
|
15.6%
10/64 • Number of events 12 • Up to 6 months per participant
|
11.5%
3/26 • Number of events 3 • Up to 6 months per participant
|
24.3%
9/37 • Number of events 12 • Up to 6 months per participant
|
25.0%
14/56 • Number of events 15 • Up to 6 months per participant
|
8.7%
8/92 • Number of events 11 • Up to 6 months per participant
|
|
General disorders
Insomnia
|
15.6%
10/64 • Number of events 10 • Up to 6 months per participant
|
11.5%
3/26 • Number of events 3 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
12.5%
7/56 • Number of events 7 • Up to 6 months per participant
|
13.0%
12/92 • Number of events 12 • Up to 6 months per participant
|
|
General disorders
Weight loss
|
15.6%
10/64 • Number of events 11 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 3 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 7 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
10.9%
10/92 • Number of events 13 • Up to 6 months per participant
|
|
General disorders
Constitutional Symptoms - Other
|
9.4%
6/64 • Number of events 10 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 6 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 7 • Up to 6 months per participant
|
10.9%
10/92 • Number of events 12 • Up to 6 months per participant
|
|
General disorders
Rigors/chills
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
10.7%
6/56 • Number of events 6 • Up to 6 months per participant
|
8.7%
8/92 • Number of events 8 • Up to 6 months per participant
|
|
General disorders
Sweating (diaphoresis)
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
10.7%
6/56 • Number of events 6 • Up to 6 months per participant
|
6.5%
6/92 • Number of events 6 • Up to 6 months per participant
|
|
General disorders
Pain - Head/headache
|
25.0%
16/64 • Number of events 17 • Up to 6 months per participant
|
23.1%
6/26 • Number of events 6 • Up to 6 months per participant
|
13.5%
5/37 • Number of events 5 • Up to 6 months per participant
|
25.0%
14/56 • Number of events 16 • Up to 6 months per participant
|
22.8%
21/92 • Number of events 23 • Up to 6 months per participant
|
|
General disorders
Pain - Back
|
17.2%
11/64 • Number of events 16 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 6 • Up to 6 months per participant
|
13.5%
5/37 • Number of events 5 • Up to 6 months per participant
|
14.3%
8/56 • Number of events 8 • Up to 6 months per participant
|
17.4%
16/92 • Number of events 17 • Up to 6 months per participant
|
|
General disorders
Pain - Bone
|
18.8%
12/64 • Number of events 13 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
10.7%
6/56 • Number of events 8 • Up to 6 months per participant
|
8.7%
8/92 • Number of events 9 • Up to 6 months per participant
|
|
General disorders
Pain - Abdomen NOS
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 3 • Up to 6 months per participant
|
21.6%
8/37 • Number of events 12 • Up to 6 months per participant
|
8.9%
5/56 • Number of events 5 • Up to 6 months per participant
|
10.9%
10/92 • Number of events 11 • Up to 6 months per participant
|
|
General disorders
Pain - Extremity-limb
|
17.2%
11/64 • Number of events 11 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 5 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 4 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 4 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
General disorders
Pain - Other
|
17.2%
11/64 • Number of events 13 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 6 • Up to 6 months per participant
|
|
General disorders
Pain - Chest/thorax NOS
|
7.8%
5/64 • Number of events 6 • Up to 6 months per participant
|
11.5%
3/26 • Number of events 4 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
8.9%
5/56 • Number of events 6 • Up to 6 months per participant
|
8.7%
8/92 • Number of events 10 • Up to 6 months per participant
|
|
General disorders
Pain - Joint
|
7.8%
5/64 • Number of events 5 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 3 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
12.5%
7/56 • Number of events 8 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 5 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
50.0%
32/64 • Number of events 32 • Up to 6 months per participant
|
57.7%
15/26 • Number of events 15 • Up to 6 months per participant
|
54.1%
20/37 • Number of events 21 • Up to 6 months per participant
|
21.4%
12/56 • Number of events 12 • Up to 6 months per participant
|
21.7%
20/92 • Number of events 22 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
34.4%
22/64 • Number of events 27 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 4 • Up to 6 months per participant
|
16.2%
6/37 • Number of events 6 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.1%
9/64 • Number of events 11 • Up to 6 months per participant
|
23.1%
6/26 • Number of events 6 • Up to 6 months per participant
|
16.2%
6/37 • Number of events 6 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 4 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
7.8%
5/64 • Number of events 7 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 5 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
Nervous system disorders
Neuropathy: sensory
|
39.1%
25/64 • Number of events 33 • Up to 6 months per participant
|
26.9%
7/26 • Number of events 9 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 5 • Up to 6 months per participant
|
19.6%
11/56 • Number of events 11 • Up to 6 months per participant
|
17.4%
16/92 • Number of events 21 • Up to 6 months per participant
|
|
General disorders
Dizziness
|
18.8%
12/64 • Number of events 13 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 5 • Up to 6 months per participant
|
16.2%
6/37 • Number of events 7 • Up to 6 months per participant
|
16.1%
9/56 • Number of events 10 • Up to 6 months per participant
|
20.7%
19/92 • Number of events 21 • Up to 6 months per participant
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 3 • Up to 6 months per participant
|
6.5%
6/92 • Number of events 6 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
23.4%
15/64 • Number of events 37 • Up to 6 months per participant
|
26.9%
7/26 • Number of events 15 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 8 • Up to 6 months per participant
|
41.1%
23/56 • Number of events 65 • Up to 6 months per participant
|
34.8%
32/92 • Number of events 79 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Neutrophils/granulocytes (ANC/AGC)
|
7.8%
5/64 • Number of events 6 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 3 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 3 • Up to 6 months per participant
|
30.4%
17/56 • Number of events 41 • Up to 6 months per participant
|
23.9%
22/92 • Number of events 43 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Platelets
|
0.00%
0/64 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 5 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
35.7%
20/56 • Number of events 40 • Up to 6 months per participant
|
21.7%
20/92 • Number of events 34 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
32.8%
21/64 • Number of events 30 • Up to 6 months per participant
|
23.1%
6/26 • Number of events 8 • Up to 6 months per participant
|
29.7%
11/37 • Number of events 13 • Up to 6 months per participant
|
32.1%
18/56 • Number of events 28 • Up to 6 months per participant
|
27.2%
25/92 • Number of events 37 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
16/64 • Number of events 18 • Up to 6 months per participant
|
19.2%
5/26 • Number of events 5 • Up to 6 months per participant
|
21.6%
8/37 • Number of events 9 • Up to 6 months per participant
|
16.1%
9/56 • Number of events 13 • Up to 6 months per participant
|
23.9%
22/92 • Number of events 25 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 3 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Edema: limb
|
23.4%
15/64 • Number of events 17 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 5 • Up to 6 months per participant
|
29.7%
11/37 • Number of events 15 • Up to 6 months per participant
|
26.8%
15/56 • Number of events 17 • Up to 6 months per participant
|
16.3%
15/92 • Number of events 18 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
20.3%
13/64 • Number of events 13 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 5 • Up to 6 months per participant
|
7.6%
7/92 • Number of events 7 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
7.8%
5/64 • Number of events 6 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 5 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 5 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
4.7%
3/64 • Number of events 4 • Up to 6 months per participant
|
15.4%
4/26 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 3 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 6 • Up to 6 months per participant
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
31.2%
20/64 • Number of events 22 • Up to 6 months per participant
|
11.5%
3/26 • Number of events 3 • Up to 6 months per participant
|
13.5%
5/37 • Number of events 5 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Eye disorders
Vision-blurred vision
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
10.8%
4/37 • Number of events 4 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 5 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Dehydration
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 4 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 3 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 2 • Up to 6 months per participant
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 3 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Pain - Throat/pharynx/larynx
|
4.7%
3/64 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 5 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 3 • Up to 6 months per participant
|
|
General disorders
Pain - Chest wall
|
3.1%
2/64 • Number of events 3 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
General disorders
Pain - Muscle
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 4 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
General disorders
Pain - Oral cavity
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.2%
4/64 • Number of events 4 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 3 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 4 • Up to 6 months per participant
|
|
Psychiatric disorders
Mood alteration - Depression
|
4.7%
3/64 • Number of events 3 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 4 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 3 • Up to 6 months per participant
|
|
General disorders
Cognitive disturbance
|
0.00%
0/64 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Low Leukocytes (total WBC)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 10 • Up to 6 months per participant
|
6.5%
6/92 • Number of events 13 • Up to 6 months per participant
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
7.8%
5/64 • Number of events 5 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
5.4%
3/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
General disorders
Hemorrhage/Bleeding - Other
|
6.2%
4/64 • Number of events 5 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 4 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 6 • Up to 6 months per participant
|
|
Infections and infestations
Febrile neutropenia
|
6.2%
4/64 • Number of events 5 • Up to 6 months per participant
|
19.2%
5/26 • Number of events 5 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 5 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
8.1%
3/37 • Number of events 4 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper
|
4.7%
3/64 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/92 • Up to 6 months per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
7.8%
5/64 • Number of events 6 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 5 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.1%
2/64 • Number of events 2 • Up to 6 months per participant
|
7.7%
2/26 • Number of events 4 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
7.6%
7/92 • Number of events 12 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.1%
2/64 • Number of events 3 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 2 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
3.3%
3/92 • Number of events 8 • Up to 6 months per participant
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
3.6%
2/56 • Number of events 5 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 3 • Up to 6 months per participant
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
1.6%
1/64 • Number of events 1 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
0.00%
0/37 • Up to 6 months per participant
|
7.1%
4/56 • Number of events 4 • Up to 6 months per participant
|
4.3%
4/92 • Number of events 4 • Up to 6 months per participant
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.7%
3/64 • Number of events 4 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
5.4%
3/56 • Number of events 3 • Up to 6 months per participant
|
2.2%
2/92 • Number of events 2 • Up to 6 months per participant
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/64 • Up to 6 months per participant
|
3.8%
1/26 • Number of events 1 • Up to 6 months per participant
|
2.7%
1/37 • Number of events 1 • Up to 6 months per participant
|
1.8%
1/56 • Number of events 1 • Up to 6 months per participant
|
5.4%
5/92 • Number of events 9 • Up to 6 months per participant
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.00%
0/64 • Up to 6 months per participant
|
0.00%
0/26 • Up to 6 months per participant
|
5.4%
2/37 • Number of events 2 • Up to 6 months per participant
|
0.00%
0/56 • Up to 6 months per participant
|
1.1%
1/92 • Number of events 1 • Up to 6 months per participant
|
Additional Information
Charles C. Williams, M.D., Study Chair
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place