Adverse Events Module

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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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT02724969
Description: Only reportable adverse events were collected/recorded for the study, and here we are only including reportable adverse events for maternal participants. Infants of participants are not included in numbers. Relevant to this, all-cause mortality does not include infants. As such, we report here that there were two infant deaths during the course of the study in the control group, and it was determined that they were unrelated to the study.
Frequency Threshold: 0
Time Frame: From study enrollment at 13-25 weeks of gestation until conclusion of the intervention and data collection of primary aims at 8 weeks postpartum
Study: NCT02724969
Study Brief: A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MILK Intervention Group Semi-automated text messages sent to participants' cellular phones 3-5 times per week beginning Week 25 of pregnancy, through 8 weeks postpartum, specific to breastfeeding support and prevention of perceived insufficient milk supply. MILK or Text4Baby text message intervention: MILK text message intervention encompasses prenatal and postpartum breastfeeding support and education text messages. Text4Baby text message intervention encompasses prenatal and postpartum text messages about pregnancy, infant care, and postpartum issues. 0 None 0 126 0 126 View
Text4Baby Control Intervention Group Text4Baby automated texts sent to participants' cellular phones 3-5 times per week from Week 25 of pregnancy through the postpartum period from the national Text4Baby system. Messages provide general prenatal and postpartum support, including breastfeeding. MILK or Text4Baby text message intervention: MILK text message intervention encompasses prenatal and postpartum breastfeeding support and education text messages. Text4Baby text message intervention encompasses prenatal and postpartum text messages about pregnancy, infant care, and postpartum issues. 0 None 0 124 0 124 View
Serious Events(If Any):
Other Events(If Any):