Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 1:05 PM
NCT ID:
NCT00472459
Description:
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.
Frequency Threshold:
1
Time Frame:
Adverse events data were reported from the first treatment up to the 27-month follow up period.
Study:
NCT00472459
Study Brief:
Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Metvix®-PDT | 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. | 0 | None | 4 | 81 | 61 | 81 | View |
| 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, 21and 27. Adverse Events localized to the contralateral Control Area. | 0 | None | 1 | 81 | 39 | 81 | View |
| All Study 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). | 6 | None | 26 | 81 | 27 | 81 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Squamous Cell Carcinoma of Skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Thyroid Gland cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.0) | View |
| Rectal Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Renal Transplant | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Knee Arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Calcus Urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Postoperative Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Neoplasm Skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Renal Impairement | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Complications of Transplanted Kidney | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Herpes Simplex Ophthalmic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Gastric Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Actinic Keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Gouty Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Parathyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Wound Secretion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Post Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Fluid Overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Scab | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin Burning Sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin Oedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Actinic Keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Angioneurotic Oedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Leukocytoclastic Vasculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Stasis Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Swelling Face | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Pain of Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Skin Nodule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |