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:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
NCT ID:
NCT01820260
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT01820260
Study Brief:
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 2: Ingenol Mebutate Gel 0.027% for 2 Days | Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days | 0 | None | 0 | 61 | 58 | 61 | View |
| Part 2: Vehicle Gel (Placebo) for 3 Days | Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days | 0 | None | 0 | 31 | 8 | 31 | View |
| Part 2: Vehicle Gel (Placebo) for 2 Days | Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days | 0 | None | 0 | 31 | 8 | 31 | View |
| Part 1A: Ingenol Mebutate Gel 0.005% | Administration on full face, once daily 3 days | 0 | None | 0 | 3 | 1 | 3 | View |
| Part 1A: Ingenol Mebutate Gel 0.008% | Administration on full face, once daily 3 days | 0 | None | 0 | 12 | 7 | 12 | View |
| Part 1A: Ingenol Mebutate Gel 0.012% | Administration on full face, once daily 3 days | 0 | None | 0 | 10 | 9 | 10 | View |
| Part 1A: Ingenol Mebutate Gel 0.018% | Administration on full face, once daily 3 days | 0 | None | 0 | 12 | 10 | 12 | View |
| Part 1A: Ingenol Mebutate Gel 0.027% | Administration on full face, once daily 3 days | 0 | None | 0 | 12 | 12 | 12 | View |
| Part 1A: Ingenol Mebutate Gel 0.04% | Administration on full face, once daily 3 days | 0 | None | 0 | 10 | 10 | 10 | View |
| Part 1B: Ingenol Mebutate Gel 0.04% | Administration on full face, once daily 2 days | 0 | None | 0 | 11 | 11 | 11 | View |
| Part 1B: Ingenol Mebutate Gel 0.06% | Administration on full face, once daily 3 days | 0 | None | 0 | 11 | 10 | 11 | View |
| Part 2: Ingenol Mebutate Gel 0.018% for 3 Days | Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days | 0 | None | 0 | 62 | 58 | 62 | View |
| Part 2: Ingenol Mebutate Gel 0.018% for 2 Days | Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days | 0 | None | 0 | 64 | 59 | 64 | View |
| Part 2: Ingenol Mebutate Gel 0.027% for 3 Days | Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days | 0 | None | 0 | 64 | 60 | 64 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Application site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Application site discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Application site paraesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Appilcation site dryness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Cyst rupture | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Nasopharyngititis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Eye swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Joint stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Application site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Application site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Tenderness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Skin burning sensation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Salivary gland neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Conjunctival hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Parosmia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Scoliosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Nasal septum deviation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| upper airway cough syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.0 | View |