Trial Outcomes & Findings for Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer (NCT NCT02916745)
NCT ID: NCT02916745
Last Updated: 2020-03-04
Results Overview
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Day 3 post-treatment
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
Photodynamic Therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
Baseline characteristics by cohort
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the intravenous injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
59.75 years
STANDARD_DEVIATION 6.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
Peripheral Lung Tumor
Primary Tumor size - baseline
|
1.70 centimetre
STANDARD_DEVIATION 0.762 • n=5 Participants
|
|
Peripheral Lung Tumor
Metastatic Tumor size - baseline
|
1.50 centimetre
STANDARD_DEVIATION 0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 post-treatmentNumber of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
One delivery of PDT into tumor
|
3 Participants
|
|
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Two deliveries of PDT into tumor
|
0 Participants
|
|
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Three deliveries of PDT into tumor
|
1 Participants
|
|
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Four deliveries of PDT into tumor
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
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|---|---|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Total number of participants with AEs
|
5 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of Blood creatinine increased
|
2 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of blood glucose increased
|
2 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of heart rate increased
|
2 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of laboratory test abnormal
|
3 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of pulmonary function test abnormal
|
3 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
AE of respiratory rate increased
|
2 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Erythema
|
2 Participants
|
|
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Atelectasis
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsFrom the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
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|---|---|
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Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Complete Response
|
1 Participants
|
|
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Partial Response
|
0 Participants
|
|
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Stable Response
|
4 Participants
|
|
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Progression of Disease
|
0 Participants
|
|
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Any response (Complete + Partial)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsFrom the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Complete Response
|
1 Participants
|
|
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Partial Response
|
0 Participants
|
|
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Stable Response
|
3 Participants
|
|
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Progression of Disease
|
1 Participants
|
|
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Any response (Complete + Partial)
|
1 Participants
|
SECONDARY outcome
Timeframe: up to day 0 (-14 to -1 days)Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 0
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 1
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 2
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayMeasured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
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|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 0
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 1
|
4 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 2
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=4 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
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|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 0
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 1
|
3 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 2
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 0
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 1
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 2
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 monthsMeasured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 0
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 1
|
2 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 2
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsMeasured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 0
|
3 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 1
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 2
|
1 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 3
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 4
|
0 Participants
|
|
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
ECOG value of 5
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselineThe Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Short Form Health Survey (SF-36) Score at Baseline
Physical Component Score (PCS)
|
49.27 score on a scale
Standard Deviation 6.71
|
|
Short Form Health Survey (SF-36) Score at Baseline
Mental Component Score
|
29.47 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: up to 3 monthsThe Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
Physical Component Score (PCS)
|
46.83 score on a scale
Standard Deviation 5.60
|
|
Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
Mental Component Score (MCS)
|
30.04 score on a scale
Standard Deviation 8.64
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
Mental Component Score (MCS)
|
31.90 score on a scale
Standard Deviation 9.61
|
|
Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
Physical Component Score (PCS)
|
48.33 score on a scale
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: BaselineBaseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Global Health Status
|
55.0 score on a scale
Standard Deviation 28.62
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Physical Functioning
|
73.34 score on a scale
Standard Deviation 10.55
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Role Functioning
|
60.02 score on a scale
Standard Deviation 30.27
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Emotional Functioning
|
80.0 score on a scale
Standard Deviation 17.29
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Cognitive Functioning
|
76.66 score on a scale
Standard Deviation 18.99
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Social Functioning
|
70.0 score on a scale
Standard Deviation 41.50
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Fatigue
|
24.44 score on a scale
Standard Deviation 25.35
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Nausea and Vomiting
|
3.34 score on a scale
Standard Deviation 7.47
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Pain
|
43.34 score on a scale
Standard Deviation 27.91
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Dyspnoea
|
53.32 score on a scale
Standard Deviation 44.73
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Insomnia
|
20.0 score on a scale
Standard Deviation 29.82
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Appetite Loss
|
26.64 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Constipation
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Diarrhoea
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Financial Difficulties
|
46.66 score on a scale
Standard Deviation 50.56
|
SECONDARY outcome
Timeframe: up to 3 months3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Fatigue
|
28.86 score on a scale
Standard Deviation 12.66
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Global Health Status
|
70.0 score on a scale
Standard Deviation 17.29
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Physical Functioning
|
68.0 score on a scale
Standard Deviation 20.76
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Role Functioning
|
63.34 score on a scale
Standard Deviation 24.73
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Emotional Functioning
|
80.02 score on a scale
Standard Deviation 12.63
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Cognitive Functioning
|
73.34 score on a scale
Standard Deviation 18.99
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Social Functioning
|
80.0 score on a scale
Standard Deviation 21.72
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Nausea and Vomiting
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Pain
|
30.0 score on a scale
Standard Deviation 29.82
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Dyspnoea
|
60.0 score on a scale
Standard Deviation 27.91
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Insomnia
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Appetite Loss
|
26.66 score on a scale
Standard Deviation 27.90
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Constipation
|
20.0 score on a scale
Standard Deviation 29.82
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Diarrhoea
|
26.66 score on a scale
Standard Deviation 27.90
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Financial Difficulties
|
33.32 score on a scale
Standard Deviation 40.83
|
SECONDARY outcome
Timeframe: Up to 6 months6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Global Health Status
|
71.66 score on a scale
Standard Deviation 20.07
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Physical Functioning
|
58.66 score on a scale
Standard Deviation 22.80
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Role Functioning
|
66.68 score on a scale
Standard Deviation 35.34
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Emotional Functioning
|
75.0 score on a scale
Standard Deviation 22.03
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Cognitive Functioning
|
76.66 score on a scale
Standard Deviation 9.09
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Social Functioning
|
76.68 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Fatigue
|
28.88 score on a scale
Standard Deviation 21.67
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Nausea and Vomiting
|
0 score on a scale
Standard Deviation 0
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Pain
|
36.66 score on a scale
Standard Deviation 13.94
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Dyspnoea
|
53.34 score on a scale
Standard Deviation 38.02
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Insomnia
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Appetite Loss
|
19.98 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Constipation
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Diarrhoea
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Financial Difficulties
|
33.32 score on a scale
Standard Deviation 40.83
|
SECONDARY outcome
Timeframe: BaselineBaseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Dyspnea
|
39.98 score on a scale
Standard Deviation 24.36
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Coughing
|
33.32 score on a scale
Standard Deviation 23.58
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Haemoptysis
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Sore Mouth
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Dysphagia
|
20.0 score on a scale
Standard Deviation 29.82
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Peripheral Neuropathy
|
19.98 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Alopecia
|
33.34 score on a scale
Standard Deviation 47.15
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Pain in Chest
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Pain in Arm or Shoulder
|
19.98 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Pain in Other Parts
|
40.0 score on a scale
Standard Deviation 27.91
|
SECONDARY outcome
Timeframe: up to 3 months3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Dyspnea
|
40.0 score on a scale
Standard Deviation 24.37
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Coughing
|
26.64 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Haemoptysis
|
0 score on a scale
Standard Deviation 0
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Sore Mouth
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Dysphagia
|
13.32 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Peripheral Neuropathy
|
19.98 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Alopecia
|
26.66 score on a scale
Standard Deviation 43.46
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Pain in Chest
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Pain in Arm or Shoulder
|
19.98 score on a scale
Standard Deviation 18.24
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Pain in Other Parts
|
66.66 score on a scale
Standard Deviation 33.35
|
SECONDARY outcome
Timeframe: Up to 6 months6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Dyspnea
|
40.0 score on a scale
Standard Deviation 30.04
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Coughing
|
39.98 score on a scale
Standard Deviation 14.94
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Haemoptysis
|
0 score on a scale
Standard Deviation 0
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Sore Mouth
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Dysphagia
|
23.66 score on a scale
Standard Deviation 43.46
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Peripheral Neuropathy
|
33.32 score on a scale
Standard Deviation 23.58
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Alopecia
|
26.66 score on a scale
Standard Deviation 43.46
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Pain in Chest
|
6.66 score on a scale
Standard Deviation 14.89
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Pain in Arm or Shoulder
|
40.0 score on a scale
Standard Deviation 27.91
|
|
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Pain in Other Parts
|
26.66 score on a scale
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: Up to 6 months post-treatmentAdverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Number of Participants With Indicated Adverse Events
Porphyria Grade 2
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Eye oedema grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Dysphagia grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Asthenia Grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Oedema peripheral grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Fall grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Trunk injury grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Blood pressure increased grade 1
|
2 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Breath sounds abnormal grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Carbon monoxide diffusing capacity decreased gr. 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Creatinine renal clearance abnormal gr. 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Heart rate increased grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Oxygen saturation decreased grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Pulmonary function test abnormal grade 1
|
2 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Respiratory rate increased grade 1
|
2 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Back pain grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Atelectasis grade 1
|
2 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Pleural effusion grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Dermatitis grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Erythema grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Erythema grade 2
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Hyperkeratosis grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Photosensitivity reaction grade 2
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Pruritus grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Rash grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Skin exfoliation grade 1
|
1 Participants with at least one event
|
|
Number of Participants With Indicated Adverse Events
Flushing grade 1
|
1 Participants with at least one event
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe number of subjects with at least one serious adverse event are listed.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Number of Subjects With at Least One Serious Adverse Event
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsSafety evaluation will include the physical examinations summary of non-normal findings for each subject.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal eyes at 3 month follow-up
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal nose, throat, ears and mouth at day 3
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at screening
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at Day 1
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at Day 3
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at Day 5
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at day 10
|
4 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at day 30
|
3 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at 3 months
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal skin at 6 months
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at screening
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at day 1
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at day 3
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at day 5
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at day 10
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at day 30
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at 3 months
|
2 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal respiratory at 6 months
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal abdomen/Gastrointestinal Day 1
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal abdomen/Gastrointestinal 3 months
|
1 Participants
|
|
Safety: Physical Examination Summaries for Each Subject
Abnormal neurological at screening
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsSafety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Safety: Number of Participants With Indicated Vital Sign Summaries
Blood pressure increased study day 180 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Vital Sign Summaries
Respiratory rate increased study day 180 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Vital Sign Summaries
Respiratory rate increased day 3 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Vital Sign Summaries
Heart rate increased day 5 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Vital Sign Summaries
Blood pressure increased day 31 grade 1
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Carbon Monoxide Diffusing Capacity down Day 92 g.1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Expiratory Reserve Volume decreased Day 92 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Forced Expiratory Volume abnormal Day 92 grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Forced Vital Capacity Abnormal Day 92 Grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Carbon Monoxide Diffusing Capacity down 3 mos. g.1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Expiratory Reserve Volume decreased 3 mos. grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Forced Expiratory Volume abnormal 3 mos. grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Forced Vital Capacity Abnormal 3 mos. Grade 1
|
1 Participants
|
|
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Oxygen Saturation decreased Day 5 grade 1
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsSafety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Safety: Laboratory Test Summaries for Each Subject
High post-baseline alkaline phosphatase
|
2 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High Alkaline Phosphatase value from baseline
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High post-baseline alanine transaminase
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High aspartate transaminase from baseline
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High creatinine levels from baseline
|
2 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High post-baseline glucose levels
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High glucose levels from baseline
|
3 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High urea nitrogen post baseline
|
2 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High protein post baseline
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High post baseline hematocrit
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
Low hematocrit values from baseline
|
2 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
Low erythrocyte count from baseline
|
2 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High erythrocyte count from baseline
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High leukocyte count from baseline
|
1 Participants
|
|
Safety: Laboratory Test Summaries for Each Subject
High leukocyte at baseline & then normal post base
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 10 days post-treatmentDistribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD45+ cells Percent gated increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD45+ cells Percent gated decreased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD45+ cells Absolute Count increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD45+ cells Absolute Count decreased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Helper T cells Percent Gated Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Helper T cells Percent Gated Decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Helper T cells Percent Gated stayed the same
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Helper T cells Absolute counts Increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Helper T cells Absolute counts Decreased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD3+, CD4+ T cells Percent Gated increased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD3+, CD4+ T cells Percent Gated decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD3+, CD4+ T cells Absolute Counts increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
CD3+, CD4+ T cells Absolute Counts decreased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
T Reg Cells Percent Gated increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
T Reg Cells Percent Gated decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
T Reg Cells Percent Gated similar
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
T Reg Cells Absolute Counts increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
T Reg Cells Absolute Counts decreased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Cytotoxic T Cells Percent Gated increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Cytotoxic T Cells Percent Gated decreased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Cytotoxic T Cells Percent Gated similar
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Cytotoxic T Cells Absolute Counts increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Cytotoxic T Cells Absolute Counts decreased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Natural Killer Cells Percent Gated increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Natural Killer Cells Percent Gated decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Natural Killer Cells Percent Gated Not Done
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Natural Killer Cells Absolute Counts increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Natural Killer Cells Absolute Counts decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
atural Killer Cells Absolute Counts Not Done
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Activated T Cells Percent Gated Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Activated T Cells Percent Gated Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Activated T Cells Absolute Counts Increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Activated T Cells Absolute Counts Decreased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
TH17 Cytokines Percent Gated Increased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
TH17 Cytokines Percent Gated Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
TH17 Cytokines Percent Gated Not Done
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
TH17 Cytokines Absolute Counts Increased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
TH17 Cytokines Absolute Counts Decreased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytic MDSCs Percent Gated Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytic MDSCs Percent Gated Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytic MDSCs Absolute Counts Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytic MDSCs Absolute Counts Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Granulocytic MDSCs Percent Gated Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Granulocytic MDSCs Percent Gated Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Granulocytic MDSCs Absolute Counts Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Granulocytic MDSCs Absolute Counts Decreased
|
2 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytes Percent Gated Increased
|
4 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytes Percent Gated Decreased
|
1 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytes Absolute Counts Increased
|
3 Participants
|
|
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Monocytes Absolute Counts Decreased
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 monthsAdverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=5 Participants
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Erythema Grade 1 Events; related
|
1 Participants
|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Erythema Grade 2 Events; related
|
1 Participants
|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Photosensitivity Reaction Grade 2; related
|
1 Participants
|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Rash grade 1; related
|
1 Participants
|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Skin Exfoliation grade 1; related
|
1 Participants
|
|
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Flushing grade 1; related
|
1 Participants
|
Adverse Events
Photodynamic Therapy-Photofrin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Photodynamic Therapy-Photofrin
n=5 participants at risk
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
|
|---|---|
|
Congenital, familial and genetic disorders
Porphyria
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Eye disorders
Eye Oedema
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
General disorders
Asthenia
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
General disorders
Peripheral Oedema
|
20.0%
1/5 • Number of events 4 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Injury, poisoning and procedural complications
Trunk Injury
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Creatinine Increased
|
40.0%
2/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Glucose Increased
|
40.0%
2/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Pressure Abnormal
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Pressure Decreased
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Pressure Diastolic Increased
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Pressure Increased
|
40.0%
2/5 • Number of events 4 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Pressure Systolic Increased
|
20.0%
1/5 • Number of events 4 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Breath Sounds Abnormal
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Carbon Monoxide diffusing capacity decreased
|
40.0%
2/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Chest X-Ray Abnormal
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Creatinine Renal Clearance Abnormal
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Expiratory Reserve Volume decreased
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Forced Expiratory Volume abnormal
|
40.0%
2/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Forced Vital Capacity abnormal
|
40.0%
2/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Haematocrit decreased
|
20.0%
1/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Haemoglobin decreased
|
20.0%
1/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Heart Rate decreased
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Heart Rate increased
|
40.0%
2/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Laboratory test abnormal
|
80.0%
4/5 • Number of events 7 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Oxygen Consumption decreased
|
20.0%
1/5 • Number of events 5 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Oxygen Saturation decreased
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Pulmonary Function Test abnormal
|
60.0%
3/5 • Number of events 5 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Red Blood Cell Count Decreased
|
40.0%
2/5 • Number of events 7 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Respiratory Rate increased
|
40.0%
2/5 • Number of events 4 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
White Blood Cell Count abnormal
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
40.0%
2/5 • Number of events 3 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
40.0%
2/5 • Number of events 11 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
20.0%
1/5 • Number of events 2 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Electrocardiogram abnormal
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Albumin increased
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Blood Urea increased
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
|
Investigations
Glomerular Filtration Rate abnormal
|
20.0%
1/5 • Number of events 1 • 6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
|
Additional Information
Kim McDonald-Taylor
on behalf of Concordia Laboratories Inc./Advanz Pharma
Phone: 647-267-2942
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place