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 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
NCT ID:
NCT02059135
Description:
Note: AEs are presented at the subject level and non-serious AE table below also includes serious AEs. Note: Initially, investigators were instructed to report all neonatal outcomes of interest (OOI) as SAEs. This requirement was removed under Protocol Amendment 4 (approximately 60% of the population). Neonatal OOI continued to be captured as outcomes but were only reported as SAEs if they met the criteria for seriousness outlined in the protocol, as determined by the investigator.
Frequency Threshold:
5
Time Frame:
Adverse events (AEs) were collected from the time of obtaining informed consent until completion of the study. AEs in the mother, while pregnant and after delivery, including those affecting the fetus, were collected up to and including the last scheduled visit, 4-6 weeks after delivery. Serious AEs (SAEs) in the neonate were collected from day of birth to the last neonate assessment, 36 weeks post-menstrual age or 4-6 week post-delivery (if 36 weeks PMA occurred < 28 days following delivery).
Study:
NCT02059135
Study Brief:
Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm 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 |
|---|---|---|---|---|---|---|---|---|
| Maternal/Fetal Safety Population: ATryn | Subjects treated with Recombinant human antithrombin (ATryn): ATryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days | 0 | None | 10 | 60 | 60 | 60 | View |
| Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | Subjects treated with Placebo; Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. | 0 | None | 11 | 54 | 53 | 54 | View |
| Neonatal Safety Population: ATryn | Neonates born to mothers treated with Recombinant Human Antithrombin (ATryn) | 3 | None | 32 | 60 | 0 | 0 | View |
| Neonatal Safety Population: Placebo | Neonates born to mothers treated with placebo (Normal Saline 0.9%) | 2 | None | 24 | 54 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| HELLP syndrome | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Intrapartum haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Abdominal Wall haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Postpartum haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Premature separation of placenta | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hypospadias | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 18.0 | View |
| Persistent foetal circulation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 18.0 | View |
| Necrotising enterocolitis neonatal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Neonatal intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Meningitis neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Sepsis neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Intraventricular haemorrhage neonatal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Periventricular leukomalacia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Premature baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Small for dates baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Bronchopulmonary dysplasia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Neonatal respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Neonatal respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Respiratory tract haemorrhage neonatal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nonreassuring foetal heart rate pattern | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Foetal growth restriction | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Postpartum depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |