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 @ 1:50 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
NCT ID:
NCT03862495
Description:
Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
Frequency Threshold:
2
Time Frame:
Through study completion, an average of 1 year.
Study:
NCT03862495
Study Brief:
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
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 Chlamydia Screening and Treatment | At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia. C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae. Azithromycin: Azithromycin 1g administered as a single oral dose Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses | 0 | None | 0 | 65 | 5 | 65 | View |
| Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment | Fetuses in utero or infants of mothers assigned chlamydia screening and treatment | 0 | None | 0 | 65 | 21 | 65 | View |
| Maternal Control | This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia. C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae. Azithromycin: Azithromycin 1g administered as a single oral dose Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses | 0 | None | 0 | 63 | 0 | 63 | View |
| Fetus or Infant of Mother Receiving Control | Fetuses in utero or infants of mothers assigned control | 0 | None | 0 | 63 | 22 | 63 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Adverse pregnancy outcomes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |