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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02851303
Description: None
Frequency Threshold: 0
Time Frame: Collected during initial hospitalization following birth for entire length of hospital stay on infants of dyads only. No infant adverse events following hospital discharge were collected. No maternal adverse events were examined/collected.
Study: NCT02851303
Study Brief: Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Morphine Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml) Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose Morphine Maintenance/Escalation * Maintain dose if score 0-8 * Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16 * Increase score by 0.06 if score 17-20 Weaning Instructions: * Maintain on dose 48 hrs before starting weaning * Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12 Re-escalation * If neonate scores 9-12 re-score as described for initiation, * If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs * If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc Morphine: Morphine wean protocol as described in arm description Adverse events were recorded only for infants of each dyad. 0 None 0 15 0 15 View
Methadone Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours Methadone: Methadone wean protocol as described in arm description Adverse events were recorded only for infants of each dyad. 0 None 0 13 3 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
High level of care transfer NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View