Trial Outcomes & Findings for Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer (NCT NCT00545948)
NCT ID: NCT00545948
Last Updated: 2014-07-21
Results Overview
Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
2 years
Results posted on
2014-07-21
Participant Flow
A total of 31 patients were registered, but 7 patients were not assigned treatment due to genomic screening failure or study ineligibility. The remaining 24 patients were assigned to the vinorelbine and pemetrexed treatment arms.
Participant milestones
| Measure |
Arm A-Vinorelbine
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
|
Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
Screen Failures
Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.
Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
7
|
|
Overall Study
Assigned Treatment
|
9
|
15
|
0
|
|
Overall Study
COMPLETED
|
8
|
14
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
7
|
Reasons for withdrawal
| Measure |
Arm A-Vinorelbine
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
|
Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
Screen Failures
Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.
Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
|
|---|---|---|---|
|
Overall Study
Not Treated
|
1
|
1
|
7
|
Baseline Characteristics
Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A-Vinorelbine
n=8 Participants
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
|
Arm B-Pemetrexed
n=14 Participants
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
Screen Failures
n=9 Participants
Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.
Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.13 years
STANDARD_DEVIATION 3.36 • n=5 Participants
|
58.93 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
61.44 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
61.18 years
STANDARD_DEVIATION 8.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
9 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.
Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.
Outcome measures
| Measure |
Treatment
n=22 Participants
Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
|
Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
|---|---|---|
|
2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC
|
63.64 percentage of treated patients
Interval 40.29 to 79.88
|
—
|
SECONDARY outcome
Timeframe: 4 yearsThe percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.
Outcome measures
| Measure |
Treatment
n=31 Participants
Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
|
Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
|---|---|---|
|
Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy
|
77.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.
Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive
Outcome measures
| Measure |
Treatment
n=22 Participants
Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
|
Arm B-Pemetrexed
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
|---|---|---|
|
2-Year Overall Survival in Patients Treated for NSCLC
|
81.81 percentage of treated patients
Interval 58.53 to 92.76
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis.
Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.
Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.
Outcome measures
Outcome data not reported
Adverse Events
Arm A-Vinorelbine
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B-Pemetrexed
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A-Vinorelbine
n=8 participants at risk
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
|
Arm B-Pemetrexed
n=14 participants at risk
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Smell alteration
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Infections and infestations - Infection with Grade 3 or 4 neutrophils : Abdomen NOS
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Infections and infestations - Infection with Grade 3 or 4 neutrophils: Blood
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Infections and infestations - Infection with Grade 3 or 4 neutrophils: Lung (pneumonia)
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Sepsis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Left interal carotid artery stenosis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
Other adverse events
| Measure |
Arm A-Vinorelbine
n=8 participants at risk
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
|
Arm B-Pemetrexed
n=14 participants at risk
Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8
No adverse events were observed for patients considered screen failures.
|
71.4%
10/14
No adverse events were observed for patients considered screen failures.
|
|
Cardiac disorders
Atrial flutter
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Tachycardia
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: vibrations and muffling
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
64.3%
9/14
No adverse events were observed for patients considered screen failures.
|
|
Eye disorders
Blurred vision
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Eye disorders
Dry eye
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Eye disorders
Eye disorders - Other, specify: Decreased visual acuity
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Eye disorders
Watering eyes
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
28.6%
4/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8
No adverse events were observed for patients considered screen failures.
|
42.9%
6/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Enterocolitis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: feeling of stomach fullness
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
28.6%
4/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
78.6%
11/14
No adverse events were observed for patients considered screen failures.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
35.7%
5/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Chills
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Edema face
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Edema limbs
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Fatigue
|
87.5%
7/8
No adverse events were observed for patients considered screen failures.
|
78.6%
11/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Fever
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
General disorders and administration site conditions - Other, specify: Smell alteration
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Injection site reaction
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
General disorders
Pain
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Immune system disorders
Immune system disorders - Other, specify: hives
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Gum infection
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Infections and infestations - Other, specify: infected cyst on neck
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Cholesterol high
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Creatinine increased
|
50.0%
4/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Investigations - Other, specify: Decreased chloride
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
28.6%
4/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Neutrophil count decreased
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
64.3%
9/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Platelet count decreased
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Weight gain
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
Weight loss
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Investigations
White blood cell decreased
|
62.5%
5/8
No adverse events were observed for patients considered screen failures.
|
35.7%
5/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
35.7%
5/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Dehydration
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
4/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
4/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Leg cramp
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Dysgeusia
|
75.0%
6/8
No adverse events were observed for patients considered screen failures.
|
35.7%
5/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Headache
|
62.5%
5/8
No adverse events were observed for patients considered screen failures.
|
57.1%
8/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Left interal carotid artery stenosis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Nervous system disorders
Tremor
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
37.5%
3/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: left base crackle/pleural rub
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
4/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
21.4%
3/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Chapped lips
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
14.3%
2/14
No adverse events were observed for patients considered screen failures.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8
No adverse events were observed for patients considered screen failures.
|
7.1%
1/14
No adverse events were observed for patients considered screen failures.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
|
Vascular disorders
Phlebitis
|
12.5%
1/8
No adverse events were observed for patients considered screen failures.
|
0.00%
0/14
No adverse events were observed for patients considered screen failures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place