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 @ 2:34 PM
Ignite Modification Date:
2025-12-25 @ 1:06 PM
NCT ID:
NCT04319159
Description:
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
Frequency Threshold:
5
Time Frame:
On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
Study:
NCT04319159
Study Brief:
Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stratum: Face/Scalp | • Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed | 0 | None | 0 | 16 | 16 | 16 | View |
| Stratum: Periphery | • Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed | 0 | None | 0 | 16 | 16 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site exfoliation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site hyperaesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site scab | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site discharge | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site discolouration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site erosion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site fissure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.0 | View |
| Application site pustules | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pyuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Application site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Application site vesicles | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |