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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT03944512
Description:
Other (not include serious) adverse events were not collected for neonates/infants. One maternal participant did not return after randomization and did not complete side effect forms.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from the time of randomization to delivery (approximately up to 30 weeks) and delivery through 2 years post-delivery (average of 24 months up to a maximum of 42.9 months). Adverse events were collected for maternal participants and their fetuses/neonates.
Study:
NCT03944512
Study Brief:
Pravastatin to Prevent Preeclampsia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 20mg Pravastatin - Mother | 20 mg pravastatin daily Pravastatin: 20 mg Pravastatin taken daily | 1 | None | 4 | 25 | 12 | 25 | View |
| Placebo - Mother | Identical appearing daily placebo Placebo: Identical appearing placebo pill | 0 | None | 5 | 25 | 11 | 24 | View |
| 20mg Pravastatin - Fetus/ Neonates /Infants | Fetus/Neonates/Infants of participants in the 20 mg Pravastatin group | 1 | None | 5 | 26 | 0 | 0 | View |
| Placebo - Fetus/ Neonates /Infants | Fetus/Neonates /Infants of participants in the placebo group | 2 | None | 5 | 26 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fetal Demise | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Termination | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neonatal death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ankyloglossia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Suspected fetal abnormality | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Hypospadias | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Poor glycemic control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Poor glycemic control and hyperemesis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Poor glycemic control and severe hypertension | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Feeding difficulty | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bowel enterotomy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| hypoxic ischemic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Uterine rupture | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Cervical insufficiency | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Bronchopulmonary dysplasia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension / preeclampsia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Maternal Death (Breast Cancer) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Muscle Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Anxiety/nervousness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Influenza-like Symptoms | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |