Trial Outcomes & Findings for Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer (NCT NCT00216125)
NCT ID: NCT00216125
Last Updated: 2016-03-16
Results Overview
A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
Participants were measured from treatment initiation to death
Results posted on
2016-03-16
Participant Flow
77 patients who started the pre-randomization arm were not randomized due to the following reasons: toxicities, disease progression, ineligibility, patient decision, death, physician decision, and other miscellaneous reasons. Only patients who were randomized to consolidation therapy or observation are included in the study analysis.
Participant milestones
| Measure |
Pre-Randomization
Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)
|
Consolidation Docetaxel
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles
|
Observation Only
Patients were followed for Observation.
|
|---|---|---|---|
|
Pre-Randomization Phase
STARTED
|
243
|
0
|
0
|
|
Pre-Randomization Phase
DSMB Cohort for Futility
|
203
|
0
|
0
|
|
Pre-Randomization Phase
COMPLETED
|
166
|
0
|
0
|
|
Pre-Randomization Phase
NOT COMPLETED
|
77
|
0
|
0
|
|
Randomization Phase
STARTED
|
0
|
84
|
82
|
|
Randomization Phase
DSMB Cohort for Futility
|
0
|
73
|
74
|
|
Randomization Phase
COMPLETED
|
0
|
73
|
74
|
|
Randomization Phase
NOT COMPLETED
|
0
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pre-Randomization
n=243 Participants
Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)
|
|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
243 participants
n=5 Participants
|
|
Percentage of participants with Stage IIIa vs IIIb disease at baseline
|
41.15 percentage
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were measured from treatment initiation to deathPopulation: The analysis cohort for the results reported below are based on a planned interim DSMB evaluation conducted in 2006. This evaluation concluded that further accrual was futile and the study should be terminated. The 203 subjects included in this analysis had data sufficiently mature at the time of the DSMB analysis.
A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.
Outcome measures
| Measure |
Consolidation Docetaxel
n=73 Participants
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles
|
Observation Only
n=74 Participants
Patients were followed for Observation.
|
|---|---|---|
|
Overall Survival
|
21.5 Months
Interval 17.0 to 34.8
|
24.1 Months
Interval 18.0 to 34.2
|
SECONDARY outcome
Timeframe: Participants were monitored from treatment initiation until disease progression per RECIST or deathA comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival. Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
Outcome measures
| Measure |
Consolidation Docetaxel
n=73 Participants
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles
|
Observation Only
n=74 Participants
Patients were followed for Observation.
|
|---|---|---|
|
Progression Free Survival
|
12.3 months
Interval 9.4 to 16.9
|
12.9 months
Interval 8.3 to 17.1
|
Adverse Events
Pre-Randomization
Serious events: 44 serious events
Other events: 63 other events
Deaths: 0 deaths
Consolidation Docetaxel
Serious events: 43 serious events
Other events: 73 other events
Deaths: 0 deaths
Observation Only
Serious events: 29 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Randomization
n=77 participants at risk
Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)
Adverse events reported in this arm consist only of participants that were not randomized into the "Consolidation Docetaxel" or "Observation Only" arms.
|
Consolidation Docetaxel
n=84 participants at risk
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles
|
Observation Only
n=82 participants at risk
Patients were followed for Observation.
|
|---|---|---|---|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
ANOREXIA
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
2.6%
2/77 • Number of events 2
|
0.00%
0/84
|
0.00%
0/82
|
|
Nervous system disorders
CNS CEREBROVASCULAR ISCHEMIA
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
DEHYDRATION
|
6.5%
5/77 • Number of events 7
|
4.8%
4/84 • Number of events 5
|
7.3%
6/82 • Number of events 6
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/77
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
3.9%
3/77 • Number of events 3
|
0.00%
0/84
|
4.9%
4/82 • Number of events 4
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
9.1%
7/77 • Number of events 7
|
6.0%
5/84 • Number of events 5
|
9.8%
8/82 • Number of events 10
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
10.4%
8/77 • Number of events 9
|
15.5%
13/84 • Number of events 15
|
4.9%
4/82 • Number of events 5
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
FISTULA, GI
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
0.00%
0/77
|
0.00%
0/84
|
4.9%
4/82 • Number of events 4
|
|
Nervous system disorders
HEMORRHAGE, CNS
|
2.6%
2/77 • Number of events 2
|
0.00%
0/84
|
0.00%
0/82
|
|
Gastrointestinal disorders
HEMORRHAGE, GI
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER
|
1.3%
1/77 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
0.00%
0/82
|
|
Cardiac disorders
HYPERTENSION
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Cardiac disorders
HYPOTENSION
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Infections and infestations
INFECTION - OTHER
|
10.4%
8/77 • Number of events 9
|
13.1%
11/84 • Number of events 13
|
6.1%
5/82 • Number of events 5
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
|
Investigations
METABOLIC/LABORATORY - OTHER
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Psychiatric disorders
MOOD ALTERATION
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
NAUSEA
|
2.6%
2/77 • Number of events 4
|
6.0%
5/84 • Number of events 6
|
0.00%
0/82
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
7.8%
6/77 • Number of events 6
|
3.6%
3/84 • Number of events 3
|
3.7%
3/82 • Number of events 3
|
|
General disorders
PAIN
|
2.6%
2/77 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
2.4%
2/82 • Number of events 2
|
|
General disorders
PAIN - OTHER
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
Blood and lymphatic system disorders
PLATELETS
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 4
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
1.3%
1/77 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.6%
2/77 • Number of events 2
|
0.00%
0/84
|
0.00%
0/82
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Psychiatric disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
|
3.9%
3/77 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
3.9%
3/77 • Number of events 3
|
3.6%
3/84 • Number of events 3
|
6.1%
5/82 • Number of events 5
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Gastrointestinal disorders
VOMITING
|
3.9%
3/77 • Number of events 5
|
6.0%
5/84 • Number of events 6
|
0.00%
0/82
|
|
General disorders
WEIGHT LOSS
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
Other adverse events
| Measure |
Pre-Randomization
n=77 participants at risk
Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33
Radiation: Radiation 5940 cGy (180 cGy/day)
Adverse events reported in this arm consist only of participants that were not randomized into the "Consolidation Docetaxel" or "Observation Only" arms.
|
Consolidation Docetaxel
n=84 participants at risk
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles
|
Observation Only
n=82 participants at risk
Patients were followed for Observation.
|
|---|---|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
1.3%
1/77 • Number of events 1
|
8.3%
7/84 • Number of events 9
|
1.2%
1/82 • Number of events 1
|
|
Investigations
ALKALINE PHOSPHATASE
|
1.3%
1/77 • Number of events 1
|
7.1%
6/84 • Number of events 7
|
4.9%
4/82 • Number of events 4
|
|
Metabolism and nutrition disorders
ALKALOSIS (METABOLIC OR RESPIRATORY)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
4.9%
4/82 • Number of events 4
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER (SPECIFY, __)
|
0.00%
0/77
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
5.2%
4/77 • Number of events 4
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
ANOREXIA
|
27.3%
21/77 • Number of events 31
|
32.1%
27/84 • Number of events 40
|
37.8%
31/82 • Number of events 41
|
|
Psychiatric disorders
APNEA
|
2.6%
2/77 • Number of events 2
|
0.00%
0/84
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
3.9%
3/77 • Number of events 4
|
1.2%
1/84 • Number of events 2
|
1.2%
1/82 • Number of events 2
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER (SPECIFY, __)
|
2.6%
2/77 • Number of events 2
|
6.0%
5/84 • Number of events 8
|
3.7%
3/82 • Number of events 4
|
|
Investigations
BICARBONATE, SERUM-LOW
|
0.00%
0/77
|
2.4%
2/84 • Number of events 3
|
0.00%
0/82
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
|
1.3%
1/77 • Number of events 1
|
3.6%
3/84 • Number of events 3
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
0.00%
0/77
|
0.00%
0/84
|
2.4%
2/82 • Number of events 3
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 2
|
0.00%
0/82
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
3.9%
3/77 • Number of events 4
|
6.0%
5/84 • Number of events 8
|
2.4%
2/82 • Number of events 3
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 3
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
10.4%
8/77 • Number of events 9
|
8.3%
7/84 • Number of events 9
|
14.6%
12/82 • Number of events 13
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
1.3%
1/77 • Number of events 1
|
4.8%
4/84 • Number of events 4
|
1.2%
1/82 • Number of events 1
|
|
Blood and lymphatic system disorders
COAGULATION - OTHER (SPECIFY, __)
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
0.00%
0/82
|
|
Gastrointestinal disorders
COLITIS
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Nervous system disorders
CONFUSION
|
3.9%
3/77 • Number of events 5
|
0.00%
0/84
|
3.7%
3/82 • Number of events 3
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.4%
8/77 • Number of events 12
|
26.2%
22/84 • Number of events 30
|
30.5%
25/82 • Number of events 29
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
0.00%
0/77
|
3.6%
3/84 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
29.9%
23/77 • Number of events 25
|
34.5%
29/84 • Number of events 41
|
45.1%
37/82 • Number of events 51
|
|
Investigations
CREATININE
|
7.8%
6/77 • Number of events 14
|
4.8%
4/84 • Number of events 4
|
4.9%
4/82 • Number of events 6
|
|
Endocrine disorders
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
DEHYDRATION
|
14.3%
11/77 • Number of events 11
|
10.7%
9/84 • Number of events 20
|
12.2%
10/82 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
3.9%
3/77 • Number of events 4
|
3.6%
3/84 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
13.0%
10/77 • Number of events 13
|
23.8%
20/84 • Number of events 29
|
13.4%
11/82 • Number of events 12
|
|
Nervous system disorders
DIZZINESS
|
6.5%
5/77 • Number of events 6
|
16.7%
14/84 • Number of events 19
|
9.8%
8/82 • Number of events 12
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/77
|
0.00%
0/84
|
3.7%
3/82 • Number of events 3
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
6.5%
5/77 • Number of events 7
|
1.2%
1/84 • Number of events 1
|
6.1%
5/82 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
44.2%
34/77 • Number of events 40
|
47.6%
40/84 • Number of events 52
|
37.8%
31/82 • Number of events 43
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
31.2%
24/77 • Number of events 36
|
42.9%
36/84 • Number of events 68
|
51.2%
42/82 • Number of events 52
|
|
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
3.7%
3/82 • Number of events 3
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
50.6%
39/77 • Number of events 70
|
51.2%
43/84 • Number of events 88
|
59.8%
49/82 • Number of events 85
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
0.00%
0/77
|
8.3%
7/84 • Number of events 7
|
2.4%
2/82 • Number of events 2
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
3.9%
3/77 • Number of events 3
|
11.9%
10/84 • Number of events 13
|
8.5%
7/82 • Number of events 9
|
|
Gastrointestinal disorders
FISTULA, GI
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
2.6%
2/77 • Number of events 4
|
10.7%
9/84 • Number of events 13
|
7.3%
6/82 • Number of events 6
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
6.5%
5/77 • Number of events 11
|
11.9%
10/84 • Number of events 26
|
6.1%
5/82 • Number of events 9
|
|
Investigations
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
27.3%
21/77 • Number of events 26
|
34.5%
29/84 • Number of events 37
|
42.7%
35/82 • Number of events 47
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
0.00%
0/77
|
1.2%
1/84 • Number of events 3
|
4.9%
4/82 • Number of events 6
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
13.0%
10/77 • Number of events 12
|
15.5%
13/84 • Number of events 17
|
20.7%
17/82 • Number of events 24
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
26.0%
20/77 • Number of events 39
|
35.7%
30/84 • Number of events 62
|
31.7%
26/82 • Number of events 39
|
|
Investigations
HEMOGLOBINURIA
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
0.00%
0/77
|
3.6%
3/84 • Number of events 5
|
2.4%
2/82 • Number of events 2
|
|
Gastrointestinal disorders
HEMORRHAGE, GI
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
|
1.3%
1/77 • Number of events 2
|
9.5%
8/84 • Number of events 8
|
3.7%
3/82 • Number of events 3
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
|
2.6%
2/77 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
1.2%
1/82 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
2.6%
2/77 • Number of events 2
|
4.8%
4/84 • Number of events 5
|
0.00%
0/82
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Cardiac disorders
HYPERTENSION
|
2.6%
2/77 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
3.7%
3/82 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
HYPOPIGMENTATION
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Cardiac disorders
HYPOTENSION
|
9.1%
7/77 • Number of events 11
|
10.7%
9/84 • Number of events 10
|
3.7%
3/82 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
2.4%
2/82 • Number of events 2
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
11.7%
9/77 • Number of events 13
|
17.9%
15/84 • Number of events 27
|
13.4%
11/82 • Number of events 17
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE REACTION/EXTRAVASATION CHANGES
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 3
|
|
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 5
|
0.00%
0/82
|
|
General disorders
INSOMNIA
|
14.3%
11/77 • Number of events 14
|
13.1%
11/84 • Number of events 13
|
23.2%
19/82 • Number of events 25
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
33.8%
26/77 • Number of events 54
|
53.6%
45/84 • Number of events 114
|
41.5%
34/82 • Number of events 63
|
|
Blood and lymphatic system disorders
LYMPHATICS - OTHER (SPECIFY, __)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.9%
3/77 • Number of events 7
|
9.5%
8/84 • Number of events 35
|
3.7%
3/82 • Number of events 6
|
|
Investigations
MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
3.9%
3/77 • Number of events 3
|
3.6%
3/84 • Number of events 9
|
0.00%
0/82
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
1.3%
1/77 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
Investigations
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
|
3.9%
3/77 • Number of events 4
|
6.0%
5/84 • Number of events 21
|
7.3%
6/82 • Number of events 14
|
|
Psychiatric disorders
MOOD ALTERATION
|
9.1%
7/77 • Number of events 11
|
19.0%
16/84 • Number of events 21
|
22.0%
18/82 • Number of events 28
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
|
2.6%
2/77 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
2.4%
2/82 • Number of events 2
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
|
14.3%
11/77 • Number of events 12
|
8.3%
7/84 • Number of events 16
|
9.8%
8/82 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
|
7.8%
6/77 • Number of events 6
|
7.1%
6/84 • Number of events 8
|
3.7%
3/82 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
3.9%
3/77 • Number of events 3
|
1.2%
1/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
NAUSEA
|
37.7%
29/77 • Number of events 44
|
38.1%
32/84 • Number of events 51
|
50.0%
41/82 • Number of events 67
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
5.2%
4/77 • Number of events 5
|
0.00%
0/84
|
0.00%
0/82
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
3.9%
3/77 • Number of events 3
|
3.6%
3/84 • Number of events 5
|
2.4%
2/82 • Number of events 3
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
9.1%
7/77 • Number of events 9
|
17.9%
15/84 • Number of events 19
|
18.3%
15/82 • Number of events 22
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
32.5%
25/77 • Number of events 38
|
59.5%
50/84 • Number of events 102
|
45.1%
37/82 • Number of events 62
|
|
Eye disorders
OCULAR/VISUAL - OTHER (SPECIFY, __)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 2
|
1.2%
1/82 • Number of events 1
|
|
General disorders
PAIN
|
24.7%
19/77 • Number of events 28
|
33.3%
28/84 • Number of events 60
|
34.1%
28/82 • Number of events 53
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
29.9%
23/77 • Number of events 41
|
31.0%
26/84 • Number of events 39
|
35.4%
29/82 • Number of events 56
|
|
Hepatobiliary disorders
PANCREATITIS
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Vascular disorders
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
PLATELETS
|
19.5%
15/77 • Number of events 31
|
28.6%
24/84 • Number of events 46
|
24.4%
20/82 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
1.3%
1/77 • Number of events 1
|
4.8%
4/84 • Number of events 5
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
2.6%
2/77 • Number of events 2
|
15.5%
13/84 • Number of events 17
|
4.9%
4/82 • Number of events 5
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
1.3%
1/77 • Number of events 1
|
3.6%
3/84 • Number of events 4
|
1.2%
1/82 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
9.1%
7/77 • Number of events 8
|
6.0%
5/84 • Number of events 12
|
4.9%
4/82 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
2.6%
2/77 • Number of events 3
|
7.1%
6/84 • Number of events 11
|
6.1%
5/82 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
9.1%
7/77 • Number of events 7
|
9.5%
8/84 • Number of events 10
|
8.5%
7/82 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION
|
13.0%
10/77 • Number of events 11
|
9.5%
8/84 • Number of events 12
|
14.6%
12/82 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
1.3%
1/77 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
4.9%
4/82 • Number of events 4
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
|
General disorders
RIGORS/CHILLS
|
2.6%
2/77 • Number of events 2
|
3.6%
3/84 • Number of events 3
|
1.2%
1/82 • Number of events 1
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/77
|
0.00%
0/84
|
1.2%
1/82 • Number of events 1
|
|
Investigations
SODIUM, SERUM-HIGH (HYPERNATREMIA)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 4
|
1.2%
1/82 • Number of events 1
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
5.2%
4/77 • Number of events 6
|
7.1%
6/84 • Number of events 9
|
6.1%
5/82 • Number of events 7
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
|
1.3%
1/77 • Number of events 1
|
6.0%
5/84 • Number of events 5
|
1.2%
1/82 • Number of events 1
|
|
General disorders
SWEATING (DIAPHORESIS)
|
1.3%
1/77 • Number of events 1
|
7.1%
6/84 • Number of events 7
|
1.2%
1/82 • Number of events 1
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
0.00%
0/77
|
6.0%
5/84 • Number of events 8
|
0.00%
0/82
|
|
General disorders
SYNDROMES - OTHER (SPECIFY, __)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
2.6%
2/77 • Number of events 2
|
0.00%
0/84
|
3.7%
3/82 • Number of events 3
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
2.6%
2/77 • Number of events 3
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Nervous system disorders
TREMOR
|
1.3%
1/77 • Number of events 1
|
0.00%
0/84
|
0.00%
0/82
|
|
Investigations
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 2
|
0.00%
0/82
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
2.6%
2/77 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
0.00%
0/77
|
2.4%
2/84 • Number of events 2
|
2.4%
2/82 • Number of events 2
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/77
|
1.2%
1/84 • Number of events 2
|
0.00%
0/82
|
|
Eye disorders
VISION-BLURRED VISION
|
0.00%
0/77
|
0.00%
0/84
|
2.4%
2/82 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
2.6%
2/77 • Number of events 2
|
7.1%
6/84 • Number of events 7
|
2.4%
2/82 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
19.5%
15/77 • Number of events 19
|
26.2%
22/84 • Number of events 24
|
18.3%
15/82 • Number of events 23
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
0.00%
0/77
|
1.2%
1/84 • Number of events 1
|
0.00%
0/82
|
|
General disorders
WEIGHT GAIN
|
1.3%
1/77 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
1.2%
1/82 • Number of events 2
|
|
General disorders
WEIGHT LOSS
|
10.4%
8/77 • Number of events 9
|
17.9%
15/84 • Number of events 20
|
14.6%
12/82 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place