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 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
NCT ID:
NCT00730405
Description:
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
Frequency Threshold:
0
Time Frame:
Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
Study:
NCT00730405
Study Brief:
Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 0 | None | 4 | 116 | 0 | 0 | View |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 1 | None | 7 | 117 | 0 | 0 | View |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 0 | None | 3 | 117 | 0 | 0 | View |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 1 | None | 6 | 117 | 0 | 0 | View |
| Placebo | Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 0 | None | 2 | 115 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Gastroenteritis salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version | View |
| Limb crushing injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version | View |
| Traumatic brain injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version | View |
| Pancreatic carcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version | View |
| Peripartum cardiomyopathy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version | View |
| Abortion induced | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version | View |
Other Events(If Any):