Safety of PDT-Photofrin® Prior to Lung Surgery

• ClinicalTrials.gov Identifier: NCT03344861
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Results First Posted: January 2, 2020
• Last Update Posted: January 13, 2020
• Sponsor: Concordia Laboratories Inc.
• Information provided by (Responsible Party): Concordia Laboratories Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Conditions: Lung Cancer; Lung Cancer Metastatic
• Interventions: Drug: Porfimer Sodium; Device: Fiber optic
• Enrollment: 10

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	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.
Period Title: Overall Study
Started	10
Completed	10
Not Completed	0

Baseline Characteristics

Arm/Group Title		Photofrin and Photodynamic Therapy
Arm/Group Description		Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT.
Overall Number of Baseline Participants		10
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	7 70.0%
	>=65 years	3 30.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	Female	4 40.0%
	Male	6 60.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	10 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	10 participants
		10
Peripheral Lung Tumor; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
		10 100.0%

Outcome Measures

1. Primary Outcome

Title	Safety: Number of Participants With at Least One Adverse Event
Description	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.
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	10 100.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photodynamic Therapy-Photofrin
	Comments	Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.
	Type of Statistical Test	Other
	Comments	No comparator arm.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	exact Clopper-Pearson binomial method
	Comments	One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.
Method of Estimation	Estimation Parameter	Clopper-Pearson (binomial proportion)
	Estimated Value	.05
	Estimation Comments	One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion

2. Primary Outcome

Title	Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Description	Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
Respiratory abnormal at screening	1 10.0%
Respiratory abnormal at Follow-up (Day 103-108)	3 30.0%
Mouth abnormal at Follow-up (day 103-108)	1 10.0%

3. Primary Outcome

Title	Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Description	Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

4. Primary Outcome

Title	Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Description	Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
Albumin (105-04) Period 1: 32 (drop of 10)	1 10.0%
Lab values with no clinically significant change	9 90.0%

5. Primary Outcome

Title	Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Description	Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	4 40.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photodynamic Therapy-Photofrin
	Comments	All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as "reasonable possibility" on the CRF (Case Report Form).
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	exact Clopper-Pearson binomial method
	Comments	One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.

6. Secondary Outcome

Title	Macroscopic Tissue Examination
Description	The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Photodynamic therapy - Photofrin

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: CM
	2.177 (0.8003)

7. Secondary Outcome

Title	Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
Description	The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Look at complete response in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: percentage of participants
	20

8. Secondary Outcome

Title	Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
Description	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.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

All subjects were examined for percent tumor cell necrosis in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Mean (Standard Deviation); Unit of Measure: Percent of tumor
	22.0 (17.67)

9. Secondary Outcome

Title	Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
Description	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.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

The brisk inflammatory reaction percentage seen in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	9 90.0%

10. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
Description	The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of participants with cavitation seen in normal lung area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	1 10.0%

11. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
Description	The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Hemorrhage seen in normal lung area after surgery

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	6 60.0%

12. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
Description	The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis.

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	2 20.0%

13. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
Description	The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	10 100.0%

14. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Description	Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination.

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	10 100.0%

15. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Description	Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

16. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Description	Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
Mild	0 0.0%
Moderate	1 10.0%
Severe	0 0.0%
None	9 90.0%

17. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Description	Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Necrosis in the normal lung after surgery

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	3 30.0%

18. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Description	Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	1 10.0%

19. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Description	Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

20. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Description	Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
	7 70.0%

21. Secondary Outcome

Title	ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Description	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).
Time Frame	Baseline (-30 to -1 Days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	7 70.0%
ECOG 1	3 30.0%

22. Secondary Outcome

Title	ECOG Performance Status: Period 1 PDT Day 3
Description	Number 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).
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	6 60.0%
ECOG 1	4 40.0%

23. Secondary Outcome

Title	ECOG Performance Status: Period II Surgery (Day 13-18)
Description	Number 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).
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	7 70.0%
ECOG 1	3 30.0%

24. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 20-25)
Description	Number 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).
Time Frame	Day 20 to 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	0 0.0%
ECOG 1	9 90.0%
ECOG 2	1 10.0%

25. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 43 -48)
Description	Number 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).
Time Frame	Day 43 to 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	7 70.0%
ECOG 1	3 30.0%

26. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Description	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).
Time Frame	108 days (to 3 months post surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description:	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.
Overall Number of Participants Analyzed	10
Measure Type: Count of Participants; Unit of Measure: Participants
ECOG 0	9 90.0%
ECOG 1	1 10.0%

Adverse Events

Time Frame	Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	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.
All-Cause Mortality
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)
Total	0/10 (0.00%)
Serious Adverse Events
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	4/10 (40.00%)
Blood and lymphatic system disorders
Hemorrhagic Shock † 1 [1]	1/10 (10.00%)	1
Anemia † 1 [2]	1/10 (10.00%)	1
Deep Vein Thrombosis (DVT) Right † 1 [3]	1/10 (10.00%)	1
Deep Vein Thrombosis Left † 1 [4]	1/10 (10.00%)	1
Cardiac disorders
Atrial Fibrillation † 1 [5]	1/10 (10.00%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage † 1 [6]	1/10 (10.00%)	1
Gastro-oesophageal reflux disease † 1 [7]	1/10 (10.00%)	1
Infections and infestations
Sepsis † 1 [8]	1/10 (10.00%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer † 1	1/10 (10.00%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion † 1 [9]	1/10 (10.00%)	1
Hypoxia † 1 [10]	1/10 (10.00%)	1
Haemothorax † 1 [11]	1/10 (10.00%)	1
Dyspnoea † 1 [12]	1/10 (10.00%)	1
Pneumonia aspiration † 1 [13]	1/10 (10.00%)	1
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment; [1] Subject hospitalized for scheduled right colectomy for colon cancer and experienced hemorrhagic shock (CTCAE Grade 4).; [2] Subject hospitalized for scheduled right colectomy for colon cancer and experienced anemia CTCAE Grade 3.; [3] Hospitalized with CTCAE Grade 3 deep vein thrombosis right.; [4] While hospitalized with DVT Right, subject experienced a CTCAE Grade 2 SAE of deep vein thrombosis left.; [5] Subject hospitalized for scheduled right colectomy for colon cancer and experienced atrial fibrillation with rapid ventricular response CTCAE Grade 2 that converted to sinus.; [6] On Study Day 4, subject received 2 doses of Toradol and on that same day complained of stomachache. On Study Days 4 & 5 subject had diarrhea. On Study Day 5 subject was diagnosed with moderate gastrointestinal bleed (CTCAE Grade 2).; [7] While hospitalized for sepsis and pneumonia aspiration, subject experience CTCAE Grade 2 SAE (Serious Adverse Event) of gastrooesophageal reflux disease; [8] Subject hospitalized with symptoms of cough, fever and chills resulting from sepsis CTCAE Grade 1.; [9] Subject hospitalized for scheduled right colectomy for colon cancer and experienced pleural effusion (recurrent right pleural effusion CTCAE Grade 2).; [10] Subject hospitalized for scheduled right colectomy for colon cancer and experienced acute hypoxemic respiratory failure CTCAE Grade 4.; [11] Subject hospitalized for scheduled right colectomy for colon cancer and experienced iatrogenic right haemothorax CTCAE Grade 3 diagnosed from CT angiogram.; [12] Subject hospitalized for scheduled right colectomy for colon cancer and experienced dyspnoea CTCAE Grade 2.; [13] Hospitalized with pneumonia aspiration CTCAE Grade 2 along with sepsis.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	10/10 (100.00%)
Cardiac disorders
Bradycardia † 1	2/10 (20.00%)	3
Tachycardia † 1	1/10 (10.00%)	1
Congenital, familial and genetic disorders
Congenital diaphragmatic hernia † 1	1/10 (10.00%)	1
Gastrointestinal disorders
Constipation † 1	2/10 (20.00%)	2
Gastritis † 1	1/10 (10.00%)	1
Nausea † 1	2/10 (20.00%)	2
Vomiting † 1	1/10 (10.00%)	1
General disorders
Tenderness † 1	1/10 (10.00%)	1
Injury, poisoning and procedural complications
Procedural Pain † 1	2/10 (20.00%)	3
Investigations
Blood albumin decreased † 1	4/10 (40.00%)	4
Blood alkaline phosphatase decreased † 1	1/10 (10.00%)	2
Blood creatinine decreased † 1	2/10 (20.00%)	4
Blood creatinine increased † 1	5/10 (50.00%)	7
Blood glucose increased † 1	3/10 (30.00%)	6
Blood pressure increased † 1	3/10 (30.00%)	8
Blood pressure decreased † 1	1/10 (10.00%)	2
Blood urea abnormal † 1	2/10 (20.00%)	3
Blood urea increased † 1	1/10 (10.00%)	1
Chest x-ray abnormal † 1	1/10 (10.00%)	2
False negative investigation result † 1	3/10 (30.00%)	6
Hematocrit decreased † 1	2/10 (20.00%)	2
Hematocrit increased † 1	2/10 (20.00%)	2
Hemoglobin decreased † 1	3/10 (30.00%)	4
Hemoglobin increased † 1	2/10 (20.00%)	2
Heart rate increased † 1	1/10 (10.00%)	1
Platelet count increased † 1	1/10 (10.00%)	1
Protein total decreased † 1	1/10 (10.00%)	1
Prothrombin time abnormal † 1	2/10 (20.00%)	2
Prothrombin time prolonged † 1	2/10 (20.00%)	2
Red blood cell count decreased † 1	2/10 (20.00%)	2
Red blood cell count increased † 1	1/10 (10.00%)	1
Respiratory rate increased † 1	1/10 (10.00%)	1
White blood cell count increased † 1	2/10 (20.00%)	4
x-ray abnormal † 1	1/10 (10.00%)	1
Blood Sodium increased † 1	1/10 (10.00%)	1
Prothrombin time shortened † 1	1/10 (10.00%)	1
Metabolism and nutrition disorders
Hyperglycaemia † 1	1/10 (10.00%)	2
Hyperkalaemia † 1	1/10 (10.00%)	2
Hypokalaemia † 1	2/10 (20.00%)	2
Hyponatraemia † 1	1/10 (10.00%)	2
Protein deficiency † 1	1/10 (10.00%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma † 1	1/10 (10.00%)	1
Lung neoplasm malignant † 1	1/10 (10.00%)	2
Neoplasm † 1	2/10 (20.00%)	2
Respiratory, thoracic and mediastinal disorders
Atelectasis † 1	4/10 (40.00%)	4
Dyspnoea † 1	1/10 (10.00%)	4
Hypoxia † 1	1/10 (10.00%)	2
Pneumothorax † 1	5/10 (50.00%)	7
Respiratory abnormal † 1	1/10 (10.00%)	1
Pleural effusion † 1	6/10 (60.00%)	7
Skin and subcutaneous tissue disorders
Swelling Face † 1 [1]	1/10 (10.00%)	1
Facial Blisters † 1 [2]	1/10 (10.00%)	1
Forearm Erythema † 1 [3]	2/10 (20.00%)	2
Hand Erythema † 1 [4]	1/10 (10.00%)	1
Facial erythema † 1 [5]	2/10 (20.00%)	3
Erythema on calves † 1 [6]	1/10 (10.00%)	1
Abdomen erythema † 1 [7]	1/10 (10.00%)	1
Hyperhidrosis † 1	1/10 (10.00%)	1
Surgical and medical procedures
Thoracic operation † 1	1/10 (10.00%)	1
Vascular disorders
Hypertension † 1	2/10 (20.00%)	6
Hypotension † 1	1/10 (10.00%)	2
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment; [1] Face swelling due to photosensitivity reaction.; [2] Blisters on face due to photosensitivity to drug.; [3] Skin erythema on both forearms; [4] Mild hand erythema from photosensitivity to study drug.; [5] Dermal erythema (sunburn) on face due to photosensitivity to study drug; [6] Dermal erythema (sunburn) on calves due to photosensitivity to study drug; [7] Abdomen redness due to photosensitivity to study drug.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kim McDonald-Taylor
• Organization: on behalf of Concordia Laboratories Inc.
• Phone: 647-267-2942
• EMail: kmcdonald-taylor@rogers.com

• Responsible Party: Concordia Laboratories Inc.
• ClinicalTrials.gov Identifier: NCT03344861
• Other Study ID Numbers: CLI-PHO1701
• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Results First Submitted: October 26, 2019
• Results First Posted: January 2, 2020
• Last Update Posted: January 13, 2020