Trial Outcomes & Findings for Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer (NCT NCT00472459)

NCT ID: NCT00472459

Last Updated: 2025-04-18

Results Overview

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: At Month 3
• Results posted on: 2025-04-18

Participant Flow

This study was conducted at 5 countries (Denmark, Germany, Norway, Sweden, and United Kingdom) between 25 July 2003 to 14 July 2006.

A total of 82 participants were randomized in the study, of which 81 participants were treated on one side of the participant (Treatment area) with Metvix®-PDT and other side of the participants (Contralateral Control Area).

Unit of analysis: Skin lesions

Participant milestones

Measure	Metvix®- PDT (Treatment Area) Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.
Overall Study STARTED	81 485	81 422
Overall Study COMPLETED	55 476	55 413
Overall Study NOT COMPLETED	26 9	26 9

Reasons for withdrawal

Measure	Metvix®- PDT (Treatment Area) Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.
Overall Study Adverse Event	13	13
Overall Study Withdrawal by Subject	5	5
Overall Study Protocol Violation	3	3
Overall Study Heavy workload, Not satisfied, Squamous Cell Carcinoma	4	4
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer

Baseline characteristics by cohort

Measure	All Study Participants n=81 Participants All participants were transplant recipients who had received immune suppressive therapy for at least 3 years and had skin lesions in each of two symmetrical contralateral areas on the face, scalp, extremities or trunk/neck received Metrvix®-PDT on one side of patient (treatment area) given as fractionated regimen on Week 0, Week 1, 3 months, 9 months and 15 months followed by other side of the patients selected area (Contralateral Control Area) was treated using lesion-specific treatment in accordance with the Investigator's preference.
Age, Continuous	57.3 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 3

Population: Intent-to-Treat (ITT) Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Accumulated New Skin Lesions at Month 3	65 new skin lesions	103 new skin lesions	—

PRIMARY outcome

Timeframe: At Month 9

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Accumulated New Skin Lesions at Month 9	92 new skin lesions	85 new skin lesions	—

PRIMARY outcome

Timeframe: At Month 15

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Accumulated New Skin Lesions at Month 15	73 new skin lesions	87 new skin lesions	—

PRIMARY outcome

Timeframe: At Month 21

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Accumulated New Skin Lesions at Month 21	55 new skin lesions	47 new skin lesions	—

PRIMARY outcome

Timeframe: At Month 27

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Accumulated New Skin Lesions at Month 27	38 new skin lesions	52 new skin lesions	—

PRIMARY outcome

Timeframe: At Month 3

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=427 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=361 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of AK Lesions That Showed Complete Response at Month 3	296 skin lesions	240 skin lesions	—

PRIMARY outcome

Timeframe: At Month 9

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=427 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=361 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of AK Lesions That Showed Complete Response at Month 9	311 skin lesions	262 skin lesions	—

PRIMARY outcome

Timeframe: At Month 15

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=427 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=361 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of AK Lesions That Showed Complete Response at Month 15	286 skin lesions	236 skin lesions	—

PRIMARY outcome

Timeframe: At Month 21

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=427 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=361 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of AK Lesions That Showed Complete Response at Month 21	275 skin lesions	224 skin lesions	—

PRIMARY outcome

Timeframe: At Month 27

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=427 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=361 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of AK Lesions That Showed Complete Response at Month 27	265 skin lesions	206 skin lesions	—

SECONDARY outcome

Timeframe: At Months 3, 9, 15, 21 and 27

Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of BCC lesions analyzed in each Arm.

Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=2 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=2 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of BCC Lesions That Showed Complete Response Month 3	1 skin lesions	2 skin lesions	—
Number of BCC Lesions That Showed Complete Response Month 9	0 skin lesions	2 skin lesions	—
Number of BCC Lesions That Showed Complete Response Month 15	0 skin lesions	2 skin lesions	—
Number of BCC Lesions That Showed Complete Response Month 21	0 skin lesions	2 skin lesions	—
Number of BCC Lesions That Showed Complete Response Month 27	1 skin lesions	2 skin lesions	—

SECONDARY outcome

Timeframe: At Months 9, 15, 21 and 27

Population: ITT population included all participants who were enrolled and treated at baseline. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.

Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=476 skin lesions Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=413 skin lesions The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Recurrent Lesions Month 9	24 skin lesions	14 skin lesions	—
Number of Recurrent Lesions Month 15	31 skin lesions	20 skin lesions	—
Number of Recurrent Lesions Month 21	12 skin lesions	8 skin lesions	—
Number of Recurrent Lesions Month 27	10 skin lesions	4 skin lesions	—

SECONDARY outcome

Timeframe: At Month 27

Population: ITT-population. Here, "overall number of participants analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for each specified category.

Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect).

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=55 Participants Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=55 Participants The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hyperpigmentation (Assessor- Participant): None	51 Participants	52 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hyperpigmentation (Assessor- Participant): Slight/Obvious	3 Participants	2 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hypopigmentation (Assessor- Investigator): None	46 Participants	27 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hypopigmentation (Assessor- Investigator): Slight/Obvious	9 Participants	28 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hypopigmentation (Assessor- Participant): None	49 Participants	36 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hypopigmentation (Assessor- Participant): Slight/Obvious	5 Participants	18 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Scar formation (Assessor- Investigator): None	48 Participants	42 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Scar formation (Assessor- Investigator): Slight/Obvious	7 Participants	13 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Scar formation (Assessor- Participant: None	47 Participants	40 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Scar formation (Assessor- Participant): Slight/Obvious	7 Participants	14 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Tissue defect (Assessor- Investigator): None	52 Participants	53 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Tissue defect (Assessor- Investigator): Slight/Obvious	3 Participants	2 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Tissue defect (Assessor- Participant): None	51 Participants	53 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Tissue defect (Assessor- Participant): Slight/Obvious	3 Participants	1 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hyperpigmentation (Assessor- Investigator): None	50 Participants	50 Participants	—
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants Hyperpigmentation (Assessor- Investigator): Slight/Obvious	5 Participants	5 Participants	—

SECONDARY outcome

Timeframe: From Baseline up to Month 27

Population: Safety Population that included in the study and received Metvix® cream were included in safety evaluation.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Metvix®- PDT (Treatment Area) n=81 Participants Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.	Contralateral Control Area n=81 Participants The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.	Not Applicable n=81 Participants Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AE	61 Participants	39 Participants	27 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAE	4 Participants	1 Participants	26 Participants

Adverse Events

Metvix®-PDT

Serious events: 4 serious events

Other events: 61 other events

Deaths: 0 deaths

Contralateral Control Area

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

All Study Participants

Serious events: 26 serious events

Other events: 27 other events

Deaths: 6 deaths

Serious adverse events

Measure	Metvix®-PDT n=81 participants at risk Two contralateral areas (symmetrically)were identified with an area of 5\*10-centimeter square,i.e., treatment and control area. Treatment area was treated with Metvix® PDT 160mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments given were given at Months 3, 9, 15, 21 and 27. Adverse Events localized to the treatment area are reported.	Contralateral Control Area n=81 participants at risk The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21and 27. Adverse Events localized to the contralateral Control Area.	All Study Participants n=81 participants at risk Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	3.7% 3/81 • Number of events 5 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	3.7% 3/81 • Number of events 4 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	2.5% 2/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Actinic Keratosis	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Sepsis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Gland cancer	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Bacteraemia	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	2.5% 2/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Immune system disorders Urosepsis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	2.5% 2/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Erysipelas	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	2.5% 2/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Vascular disorders Haematoma	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Surgical and medical procedures Parathyroidectomy	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Surgical and medical procedures Renal Transplant	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Injury, poisoning and procedural complications Wound Secretion	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Renal and urinary disorders Calcus Urinary	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Postoperative Infection	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Injury, poisoning and procedural complications Post Procedural Pain	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Skin	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Renal and urinary disorders Renal Impairement	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Gastrointestinal disorders Ascites	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Injury, poisoning and procedural complications Fall	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Urinary Tract Infection	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	3.7% 3/81 • Number of events 3 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Gastrointestinal disorders Diarrhoea	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Injury, poisoning and procedural complications Complications of Transplanted Kidney	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	2.5% 2/81 • Number of events 2 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Eye disorders Vision Blurred	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Herpes Simplex Ophthalmic	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Eye disorders Keratitis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Vascular disorders Deep Vein Thrombosis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Infections and infestations Pneumonia	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Number of events 1 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.

Other adverse events

Measure	Metvix®-PDT n=81 participants at risk Two contralateral areas (symmetrically)were identified with an area of 5\*10-centimeter square,i.e., treatment and control area. Treatment area was treated with Metvix® PDT 160mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments given were given at Months 3, 9, 15, 21 and 27. Adverse Events localized to the treatment area are reported.	Contralateral Control Area n=81 participants at risk The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21and 27. Adverse Events localized to the contralateral Control Area.	All Study Participants n=81 participants at risk Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).
Skin and subcutaneous tissue disorders Erythema	65.4% 53/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	27.2% 22/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Pain of Skin	54.3% 44/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	39.5% 32/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Scab	23.5% 19/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	17.3% 14/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin Burning Sensation	9.9% 8/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin Oedema	8.6% 7/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	3.7% 3/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin exfoliation	6.2% 5/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Blister	2.5% 2/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	12.3% 10/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Pruritus	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Rash papular	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin ulcer	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Actinic Keratosis	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	27.2% 22/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Neurodermatitis	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Eczema	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	6.2% 5/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Angioneurotic Oedema	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Leukocytoclastic Vasculitis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Skin Nodule	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Stasis Dermatitis	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.
Skin and subcutaneous tissue disorders Swelling Face	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	0.00% 0/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.	1.2% 1/81 • Adverse events data were reported from the first treatment up to the 27-month follow up period. Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: Clinical.Studies@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER