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 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
NCT ID:
NCT03124160
Description:
None
Frequency Threshold:
5
Time Frame:
3 years
Study:
NCT03124160
Study Brief:
Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mona Lisa® NT Cu380 Mini | Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity. Mona Lisa® NT Cu380 Mini: Mona Lisa® NT Cu380 Mini | 0 | None | 32 | 887 | 742 | 875 | View |
| ParaGard® TCu380A | ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity. ParaGard® TCu380A: ParaGard® TCu380A | 0 | None | 3 | 218 | 183 | 213 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| uterine perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.1) | View |
| ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (23.1) | View |
| premature delivery | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (23.1) | View |
| appendicectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (23.1) | View |
| thyroid nodule removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (23.1) | View |
| myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| ovarian mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| pre-eclampsia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| infected bite | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| tubo-ovarian abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| inflammatory bowel disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| oesophageal achalasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| suicidal attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| dependence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| open fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| uterine spasm | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| bacterial vaginosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |