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 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
NCT ID:
NCT00620035
Description:
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
Frequency Threshold:
5
Time Frame:
Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
Study:
NCT00620035
Study Brief:
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Radiopaque Etonogestrel Implant | The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray. The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year. | None | None | 17 | 301 | 233 | 301 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | None | Infections and infestations | MedDRA (13.1) | View |
| Breast Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Thyroid Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Depression | None | Psychiatric disorders | MedDRA (13.1) | View |
| Suicide Attempt | None | Psychiatric disorders | MedDRA (13.1) | View |
| Ovarian Cyst | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Calculus Urinary | None | Renal and urinary disorders | MedDRA (13.1) | View |
| Abdominal Pain | None | Gastrointestinal disorders | MedDRA (13.1) | View |
| Jaundice | None | Hepatobiliary disorders | MedDRA (13.1) | View |
| Campylobacter gastroenteritis | None | Infections and infestations | MedDRA (13.1) | View |
| Salpingo-oophoritis | None | Infections and infestations | MedDRA (13.1) | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA (13.1) | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Lethargy | None | Nervous system disorders | MedDRA (13.1) | View |
| Migraine | None | Nervous system disorders | MedDRA (13.1) | View |
| Sciatica | None | Nervous system disorders | MedDRA (13.1) | View |
| Bipolar Disorder | None | Psychiatric disorders | MedDRA (13.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Implant Site Haematoma | None | General disorders | MedDRA (13.1) | View |
| Implant Site Pain | None | General disorders | MedDRA (13.1) | View |
| Influenza | None | Infections and infestations | MedDRA (13.1) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (13.1) | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA (13.1) | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA (13.1) | View |
| Vulvovaginal Candidiasis | None | Infections and infestations | MedDRA (13.1) | View |
| Weight Increased | None | Investigations | MedDRA (13.1) | View |
| Headache | None | Nervous system disorders | MedDRA (13.1) | View |
| Amenorrhoea | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Dysmenorrhoea | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Menorrhagia | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Metrorrhagia | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Vaginal Haemorrhage | None | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Acne | None | Reproductive system and breast disorders | MedDRA (13.1) | View |