Non-small Cell Lung Cancer (NSCLC), Lung Metastasis
Conditions
Keywords
Non-small cell lung cancer, NSCLC, lung cancer, lung carcinoma, lung metastasis
Brief summary
This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.
Detailed description
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location. Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber optic device (very fine fiber \[like a fishing line\] that permits light transmission) inserted into a flexible tube called bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction. The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumor.
Interventions
DRUGPorfimer sodium
After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
DEVICEFiber optic
A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Sponsors
Concordia Laboratories Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 or older * Diagnosed with histologically confirmed solid tumor located in the peripheral lung * Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery * May be candidate for, have failed, or does not wish to undergo radiation therapy * The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan) * Able to sign an informed consent
Exclusion criteria
* Diagnostic of small cell lung cancer * Solid tumor located in central lung * Presence of concurrent non-solid malignancy * Abnormal blood results * Received chemotherapy/immunotherapy in the last 4 weeks * Tumor invades a major blood vessel * Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients * Planned surgical procedure within the next 90 days * Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days * Acute or chronic medical or psychological illnesses that prevent endoscopy procedures * Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study * Received PDT during the past 3 months * Severe impairment of your kidney or liver function * Participates or intends to participate in another drug study (other than observational studies) during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor | Day 3 post-treatment | Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject. |
| Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | Up to 6 months | The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Up to 6 months | From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | up to day 0 (-14 to -1 days) | Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | 1 day | Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | Day 3 | Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | Day 30 | Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | up to 3 months | Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | Up to 6 months | Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair. |
| Short Form Health Survey (SF-36) Score at Baseline | Baseline | The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints. |
| Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months. | up to 3 months | The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints. |
| Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit) | Up to 6 months | The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints. |
| Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | up to 3 months | 3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden. |
| Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Up to 6 months | 6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden. |
| Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Baseline | Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom. |
| Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | up to 3 months | 3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom. |
| Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Up to 6 months | 6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom. |
| Number of Participants With Indicated Adverse Events | Up to 6 months post-treatment | Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1 |
| Number of Subjects With at Least One Serious Adverse Event | Up to 6 months | The number of subjects with at least one serious adverse event are listed. |
| Safety: Physical Examination Summaries for Each Subject | Up to 6 months | Safety evaluation will include the physical examinations summary of non-normal findings for each subject. |
| Safety: Number of Participants With Indicated Vital Sign Summaries | Up to 6 months | Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health. |
| Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Up to 6 months | The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL) |
| Safety: Laboratory Test Summaries for Each Subject | Up to 6 months | Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein) |
| Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Baseline | Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden. |
| Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Up to 3 months | From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Baseline, 10 days post-treatment | Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture. |
| Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Up to 6 months | Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photodynamic Therapy-Photofrin Photodynamic therapy (PDT) involves the intravenous injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Photodynamic Therapy-Photofrin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 59.75 years STANDARD_DEVIATION 6.99 |
| Peripheral Lung Tumor Metastatic Tumor size - baseline | 1.50 centimetre STANDARD_DEVIATION 0 |
| Peripheral Lung Tumor Primary Tumor size - baseline | 1.70 centimetre STANDARD_DEVIATION 0.762 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | Total number of participants with AEs | 5 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of Blood creatinine increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of blood glucose increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of heart rate increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of laboratory test abnormal | 3 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of pulmonary function test abnormal | 3 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | AE of respiratory rate increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | Erythema | 2 Participants |
| Photodynamic Therapy-Photofrin | Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) | Atelectasis | 2 Participants |
Primary
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Time frame: Day 3 post-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor | One delivery of PDT into tumor | 3 Participants |
| Photodynamic Therapy-Photofrin | Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor | Two deliveries of PDT into tumor | 0 Participants |
| Photodynamic Therapy-Photofrin | Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor | Three deliveries of PDT into tumor | 1 Participants |
| Photodynamic Therapy-Photofrin | Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor | Four deliveries of PDT into tumor | 1 Participants |
Secondary
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Financial Difficulties | 33.32 score on a scale | Standard Deviation 40.83 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Global Health Status | 71.66 score on a scale | Standard Deviation 20.07 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Physical Functioning | 58.66 score on a scale | Standard Deviation 22.8 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Role Functioning | 66.68 score on a scale | Standard Deviation 35.34 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Emotional Functioning | 75.0 score on a scale | Standard Deviation 22.03 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Cognitive Functioning | 76.66 score on a scale | Standard Deviation 9.09 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Social Functioning | 76.68 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Fatigue | 28.88 score on a scale | Standard Deviation 21.67 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Nausea and Vomiting | 0 score on a scale | Standard Deviation 0 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Pain | 36.66 score on a scale | Standard Deviation 13.94 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Dyspnoea | 53.34 score on a scale | Standard Deviation 38.02 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Insomnia | 13.32 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Appetite Loss | 19.98 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Constipation | 13.32 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months | Diarrhoea | 13.32 score on a scale | Standard Deviation 18.24 |
Secondary
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Global Health Status | 55.0 score on a scale | Standard Deviation 28.62 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Physical Functioning | 73.34 score on a scale | Standard Deviation 10.55 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Role Functioning | 60.02 score on a scale | Standard Deviation 30.27 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Emotional Functioning | 80.0 score on a scale | Standard Deviation 17.29 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Cognitive Functioning | 76.66 score on a scale | Standard Deviation 18.99 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Social Functioning | 70.0 score on a scale | Standard Deviation 41.5 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Fatigue | 24.44 score on a scale | Standard Deviation 25.35 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Nausea and Vomiting | 3.34 score on a scale | Standard Deviation 7.47 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Pain | 43.34 score on a scale | Standard Deviation 27.91 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Dyspnoea | 53.32 score on a scale | Standard Deviation 44.73 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Insomnia | 20.0 score on a scale | Standard Deviation 29.82 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Appetite Loss | 26.64 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Constipation | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Diarrhoea | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline | Financial Difficulties | 46.66 score on a scale | Standard Deviation 50.56 |
Secondary
Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time frame: up to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Global Health Status | 70.0 score on a scale | Standard Deviation 17.29 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Physical Functioning | 68.0 score on a scale | Standard Deviation 20.76 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Role Functioning | 63.34 score on a scale | Standard Deviation 24.73 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Emotional Functioning | 80.02 score on a scale | Standard Deviation 12.63 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Cognitive Functioning | 73.34 score on a scale | Standard Deviation 18.99 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Social Functioning | 80.0 score on a scale | Standard Deviation 21.72 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Fatigue | 28.86 score on a scale | Standard Deviation 12.66 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Nausea and Vomiting | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Pain | 30.0 score on a scale | Standard Deviation 29.82 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Dyspnoea | 60.0 score on a scale | Standard Deviation 27.91 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Insomnia | 13.32 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Appetite Loss | 26.66 score on a scale | Standard Deviation 27.9 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Constipation | 20.0 score on a scale | Standard Deviation 29.82 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Diarrhoea | 26.66 score on a scale | Standard Deviation 27.9 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months | Financial Difficulties | 33.32 score on a scale | Standard Deviation 40.83 |
Secondary
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Dysphagia | 20.0 score on a scale | Standard Deviation 29.82 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Dyspnea | 39.98 score on a scale | Standard Deviation 24.36 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Coughing | 33.32 score on a scale | Standard Deviation 23.58 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Haemoptysis | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Sore Mouth | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Peripheral Neuropathy | 19.98 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Alopecia | 33.34 score on a scale | Standard Deviation 47.15 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Pain in Chest | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Pain in Arm or Shoulder | 19.98 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score | Pain in Other Parts | 40.0 score on a scale | Standard Deviation 27.91 |
Secondary
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time frame: up to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Dyspnea | 40.0 score on a scale | Standard Deviation 24.37 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Coughing | 26.64 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Haemoptysis | 0 score on a scale | Standard Deviation 0 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Sore Mouth | 13.32 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Dysphagia | 13.32 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Peripheral Neuropathy | 19.98 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Alopecia | 26.66 score on a scale | Standard Deviation 43.46 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Pain in Chest | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Pain in Arm or Shoulder | 19.98 score on a scale | Standard Deviation 18.24 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score | Pain in Other Parts | 66.66 score on a scale | Standard Deviation 33.35 |
Secondary
Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Dyspnea | 40.0 score on a scale | Standard Deviation 30.04 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Coughing | 39.98 score on a scale | Standard Deviation 14.94 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Haemoptysis | 0 score on a scale | Standard Deviation 0 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Sore Mouth | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Dysphagia | 23.66 score on a scale | Standard Deviation 43.46 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Peripheral Neuropathy | 33.32 score on a scale | Standard Deviation 23.58 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Alopecia | 26.66 score on a scale | Standard Deviation 43.46 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Pain in Chest | 6.66 score on a scale | Standard Deviation 14.89 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Pain in Arm or Shoulder | 40.0 score on a scale | Standard Deviation 27.91 |
| Photodynamic Therapy-Photofrin | Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score | Pain in Other Parts | 26.66 score on a scale | Standard Deviation 27.9 |
Secondary
Number of Participants With Indicated Adverse Events
Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1
Time frame: Up to 6 months post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Porphyria Grade 2 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Eye oedema grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Dysphagia grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Asthenia Grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Oedema peripheral grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Fall grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Trunk injury grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Blood pressure increased grade 1 | 2 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Breath sounds abnormal grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Carbon monoxide diffusing capacity decreased gr. 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Creatinine renal clearance abnormal gr. 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Heart rate increased grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Oxygen saturation decreased grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Pulmonary function test abnormal grade 1 | 2 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Respiratory rate increased grade 1 | 2 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Back pain grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Atelectasis grade 1 | 2 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Pleural effusion grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Dermatitis grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Erythema grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Erythema grade 2 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Hyperkeratosis grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Photosensitivity reaction grade 2 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Pruritus grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Rash grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Skin exfoliation grade 1 | 1 Participants with at least one event |
| Photodynamic Therapy-Photofrin | Number of Participants With Indicated Adverse Events | Flushing grade 1 | 1 Participants with at least one event |
Secondary
Number of Subjects With at Least One Serious Adverse Event
The number of subjects with at least one serious adverse event are listed.
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Photodynamic Therapy-Photofrin | Number of Subjects With at Least One Serious Adverse Event | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: up to 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 0 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 1 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 2 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection | ECOG value of 5 | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 0 | 3 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 2 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection | ECOG value of 5 | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 0 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 1 | 4 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 2 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). | ECOG value of 5 | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: Day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 2 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 0 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 1 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) | ECOG value of 5 | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: Day 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 0 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 1 | 3 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 2 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) | ECOG value of 5 | 0 Participants |
Secondary
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about \>50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair \>50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time frame: up to day 0 (-14 to -1 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 0 | 1 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 1 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 2 | 2 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 3 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 4 | 0 Participants |
| Photodynamic Therapy-Photofrin | Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. | ECOG value of 5 | 0 Participants |
Secondary
Safety: Laboratory Test Summaries for Each Subject
Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High erythrocyte count from baseline | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High post-baseline alkaline phosphatase | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High Alkaline Phosphatase value from baseline | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High post-baseline alanine transaminase | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High aspartate transaminase from baseline | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High creatinine levels from baseline | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High post-baseline glucose levels | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High glucose levels from baseline | 3 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High urea nitrogen post baseline | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High protein post baseline | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High post baseline hematocrit | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | Low hematocrit values from baseline | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | Low erythrocyte count from baseline | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High leukocyte count from baseline | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Laboratory Test Summaries for Each Subject | High leukocyte at baseline & then normal post base | 1 Participants |
Secondary
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Carbon Monoxide Diffusing Capacity down Day 92 g.1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Expiratory Reserve Volume decreased Day 92 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Forced Expiratory Volume abnormal Day 92 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Forced Vital Capacity Abnormal Day 92 Grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Carbon Monoxide Diffusing Capacity down 3 mos. g.1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Expiratory Reserve Volume decreased 3 mos. grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Forced Expiratory Volume abnormal 3 mos. grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Forced Vital Capacity Abnormal 3 mos. Grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events | Oxygen Saturation decreased Day 5 grade 1 | 1 Participants |
Secondary
Safety: Number of Participants With Indicated Vital Sign Summaries
Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Vital Sign Summaries | Blood pressure increased study day 180 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Vital Sign Summaries | Respiratory rate increased study day 180 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Vital Sign Summaries | Respiratory rate increased day 3 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Vital Sign Summaries | Heart rate increased day 5 grade 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Number of Participants With Indicated Vital Sign Summaries | Blood pressure increased day 31 grade 1 | 1 Participants |
Secondary
Safety: Physical Examination Summaries for Each Subject
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at day 10 | 4 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal eyes at 3 month follow-up | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal nose, throat, ears and mouth at day 3 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at screening | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at Day 1 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at Day 3 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at Day 5 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at day 30 | 3 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at 3 months | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal skin at 6 months | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at screening | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at day 1 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at day 3 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at day 5 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at day 10 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at day 30 | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at 3 months | 2 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal respiratory at 6 months | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal abdomen/Gastrointestinal Day 1 | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal abdomen/Gastrointestinal 3 months | 1 Participants |
| Photodynamic Therapy-Photofrin | Safety: Physical Examination Summaries for Each Subject | Abnormal neurological at screening | 1 Participants |
Secondary
Short Form Health Survey (SF-36) Score at Baseline
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Short Form Health Survey (SF-36) Score at Baseline | Physical Component Score (PCS) | 49.27 score on a scale | Standard Deviation 6.71 |
| Photodynamic Therapy-Photofrin | Short Form Health Survey (SF-36) Score at Baseline | Mental Component Score | 29.47 score on a scale | Standard Deviation 3.13 |
Secondary
Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time frame: up to 3 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months. | Physical Component Score (PCS) | 46.83 score on a scale | Standard Deviation 5.6 |
| Photodynamic Therapy-Photofrin | Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months. | Mental Component Score (MCS) | 30.04 score on a scale | Standard Deviation 8.64 |
Secondary
Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Therapy-Photofrin | Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit) | Physical Component Score (PCS) | 48.33 score on a scale | Standard Deviation 7.45 |
| Photodynamic Therapy-Photofrin | Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit) | Mental Component Score (MCS) | 31.90 score on a scale | Standard Deviation 9.61 |
Secondary
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time frame: Up to 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Complete Response | 1 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Partial Response | 0 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Stable Response | 4 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Progression of Disease | 0 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at 3 Months Post Photodynamic Therapy (PDT) | Any response (Complete + Partial) | 1 Participants |
Secondary
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Progression of Disease | 1 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Complete Response | 1 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Partial Response | 0 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Stable Response | 3 Participants |
| Photodynamic Therapy-Photofrin | Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) | Any response (Complete + Partial) | 1 Participants |
Other Pre-specified
Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture.
Time frame: Baseline, 10 days post-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD3+, CD4+ T cells Percent Gated decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD3+, CD4+ T cells Absolute Counts increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD3+, CD4+ T cells Absolute Counts decreased | 4 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | T Reg Cells Percent Gated increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | T Reg Cells Percent Gated decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | T Reg Cells Percent Gated similar | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | T Reg Cells Absolute Counts increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | T Reg Cells Absolute Counts decreased | 4 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Cytotoxic T Cells Percent Gated increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Cytotoxic T Cells Percent Gated decreased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Cytotoxic T Cells Percent Gated similar | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Cytotoxic T Cells Absolute Counts increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Cytotoxic T Cells Absolute Counts decreased | 4 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Natural Killer Cells Percent Gated increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Natural Killer Cells Percent Gated decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Natural Killer Cells Percent Gated Not Done | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Natural Killer Cells Absolute Counts increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Natural Killer Cells Absolute Counts decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | atural Killer Cells Absolute Counts Not Done | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Activated T Cells Percent Gated Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Activated T Cells Percent Gated Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Activated T Cells Absolute Counts Increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Activated T Cells Absolute Counts Decreased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | TH17 Cytokines Percent Gated Increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | TH17 Cytokines Percent Gated Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | TH17 Cytokines Percent Gated Not Done | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | TH17 Cytokines Absolute Counts Increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | TH17 Cytokines Absolute Counts Decreased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytic MDSCs Percent Gated Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytic MDSCs Percent Gated Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytic MDSCs Absolute Counts Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytic MDSCs Absolute Counts Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Granulocytic MDSCs Percent Gated Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Granulocytic MDSCs Percent Gated Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Granulocytic MDSCs Absolute Counts Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Granulocytic MDSCs Absolute Counts Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytes Percent Gated Increased | 4 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytes Percent Gated Decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytes Absolute Counts Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Monocytes Absolute Counts Decreased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD45+ cells Percent gated increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD45+ cells Percent gated decreased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD45+ cells Absolute Count increased | 2 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD45+ cells Absolute Count decreased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Helper T cells Percent Gated Increased | 3 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Helper T cells Percent Gated Decreased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Helper T cells Percent Gated stayed the same | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Helper T cells Absolute counts Increased | 1 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | Helper T cells Absolute counts Decreased | 4 Participants |
| Photodynamic Therapy-Photofrin | Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. | CD3+, CD4+ T cells Percent Gated increased | 4 Participants |
Other Pre-specified
Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Erythema Grade 1 Events; related | 1 Participants |
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Erythema Grade 2 Events; related | 1 Participants |
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Photosensitivity Reaction Grade 2; related | 1 Participants |
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Rash grade 1; related | 1 Participants |
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Skin Exfoliation grade 1; related | 1 Participants |
| Photodynamic Therapy-Photofrin | Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event | Flushing grade 1; related | 1 Participants |