Trial Outcomes & Findings for Safety of PDT-Photofrin® Prior to Lung Surgery (NCT NCT03344861)
NCT ID: NCT03344861
Last Updated: 2020-01-13
Results Overview
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
108 days (to 3 months post surgery)
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
Photodynamic Therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of PDT-Photofrin® Prior to Lung Surgery
Baseline characteristics by cohort
| Measure |
Photofrin and Photodynamic Therapy
n=10 Participants
Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=99 Participants
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Age, Categorical
>=65 years
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3 Participants
n=99 Participants
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Sex: Female, Male
Female
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4 Participants
n=99 Participants
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Sex: Female, Male
Male
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6 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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10 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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10 participants
n=99 Participants
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Peripheral Lung Tumor
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10 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 108 days (to 3 months post surgery)Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Safety: Number of Participants With at Least One Adverse Event
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10 Participants
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PRIMARY outcome
Timeframe: 108 days (to 3 months post surgery)Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Respiratory abnormal at screening
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1 Participants
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Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Respiratory abnormal at Follow-up (Day 103-108)
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3 Participants
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Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Mouth abnormal at Follow-up (day 103-108)
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1 Participants
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PRIMARY outcome
Timeframe: 108 days (to 3 months post surgery)Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Safety: Vital Sign Summary of Abnormal Findings for Each Subject
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0 Participants
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PRIMARY outcome
Timeframe: 108 days (to 3 months post surgery)Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Albumin (105-04) Period 1: 32 (drop of 10)
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1 Participants
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Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Lab values with no clinically significant change
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9 Participants
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PRIMARY outcome
Timeframe: 108 days (to 3 months post surgery)Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
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4 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Photodynamic therapy - Photofrin
The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Macroscopic Tissue Examination
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2.177 CM
Standard Deviation 0.8003
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Look at complete response in the tumor area
The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
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20 percentage of participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: All subjects were examined for percent tumor cell necrosis in the tumor area
The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
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22.0 Percent of tumor
Standard Deviation 17.67
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SECONDARY outcome
Timeframe: Day 13 to 18Population: The brisk inflammatory reaction percentage seen in the tumor area
The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
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9 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Number of participants with cavitation seen in normal lung area
The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
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1 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Number of Participants with Hemorrhage seen in normal lung area after surgery
The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
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6 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis.
The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
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2 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
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10 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Population: Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination.
Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
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10 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
|
0 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Mild
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0 Participants
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Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Moderate
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1 Participants
|
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Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Severe
|
0 Participants
|
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Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
None
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 13 to 18Population: Number of Participants with Necrosis in the normal lung after surgery
Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
|
3 Participants
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SECONDARY outcome
Timeframe: Day 13 to 18Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 13 to 18Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 13 to 18Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (-30 to -1 Days)Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
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|---|---|
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ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
ECOG 0
|
7 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
ECOG 1
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 3Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
ECOG Performance Status: Period 1 PDT Day 3
ECOG 0
|
6 Participants
|
|
ECOG Performance Status: Period 1 PDT Day 3
ECOG 1
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 13 to 18Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
ECOG Performance Status: Period II Surgery (Day 13-18)
ECOG 0
|
7 Participants
|
|
ECOG Performance Status: Period II Surgery (Day 13-18)
ECOG 1
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 20 to 25Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
ECOG Performance Status: Period III Follow-up (Day 20-25)
ECOG 0
|
0 Participants
|
|
ECOG Performance Status: Period III Follow-up (Day 20-25)
ECOG 1
|
9 Participants
|
|
ECOG Performance Status: Period III Follow-up (Day 20-25)
ECOG 2
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 43 to 48Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
ECOG Performance Status: Period III Follow-up (Day 43 -48)
ECOG 0
|
7 Participants
|
|
ECOG Performance Status: Period III Follow-up (Day 43 -48)
ECOG 1
|
3 Participants
|
SECONDARY outcome
Timeframe: 108 days (to 3 months post surgery)Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Outcome measures
| Measure |
Photodynamic Therapy-Photofrin
n=10 Participants
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
ECOG 0
|
9 Participants
|
|
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
ECOG 1
|
1 Participants
|
Adverse Events
Photodynamic Therapy-Photofrin
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Photodynamic Therapy-Photofrin
n=10 participants at risk
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Blood and lymphatic system disorders
Hemorrhagic Shock
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis (DVT) Right
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis Left
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
Other adverse events
| Measure |
Photodynamic Therapy-Photofrin
n=10 participants at risk
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
40.0%
4/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
5/10 • Number of events 7 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory abnormal
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Surgical and medical procedures
Thoracic operation
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 6 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood Sodium increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
60.0%
6/10 • Number of events 7 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Prothrombin time shortened
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Facial Blisters
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Forearm Erythema
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Hand Erythema
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Facial erythema
|
20.0%
2/10 • Number of events 3 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Erythema on calves
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Skin and subcutaneous tissue disorders
Abdomen erythema
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Cardiac disorders
Bradycardia
|
20.0%
2/10 • Number of events 3 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Congenital, familial and genetic disorders
Congenital diaphragmatic hernia
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
General disorders
Tenderness
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
20.0%
2/10 • Number of events 3 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood albumin decreased
|
40.0%
4/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood alkaline phosphatase decreased
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood creatinine decreased
|
20.0%
2/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood creatinine increased
|
50.0%
5/10 • Number of events 7 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood glucose increased
|
30.0%
3/10 • Number of events 6 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood pressure increased
|
30.0%
3/10 • Number of events 8 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood pressure decreased
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood urea abnormal
|
20.0%
2/10 • Number of events 3 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Chest x-ray abnormal
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
False negative investigation result
|
30.0%
3/10 • Number of events 6 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Hematocrit decreased
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Hematocrit increased
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Hemoglobin decreased
|
30.0%
3/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Hemoglobin increased
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Heart rate increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Platelet count increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Protein total decreased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Prothrombin time abnormal
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Prothrombin time prolonged
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Red blood cell count decreased
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Red blood cell count increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
Respiratory rate increased
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
White blood cell count increased
|
20.0%
2/10 • Number of events 4 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Investigations
x-ray abnormal
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Number of events 2 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
|
Metabolism and nutrition disorders
Protein deficiency
|
10.0%
1/10 • Number of events 1 • Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
|
Additional Information
Kim McDonald-Taylor
on behalf of Concordia Laboratories Inc.
Phone: 647-267-2942
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place