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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
NCT ID:
NCT03187834
Description:
On each day of treatment, caregivers were asked if the child had any symptoms since the previous day, including gastrointestinal symptoms, respiratory symptoms, a rash, or any other symptoms. Four days after the last treatment dose, caregivers were asked if their child had had three or more loose or watery stools over a 24-hour period, consistent with the WHO definition of diarrhea,21 and if the child currently had a cough or difficulty breathing.
Frequency Threshold:
0
Time Frame:
days 1-5
Study:
NCT03187834
Study Brief:
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Amoxicillin Households - Antibiotic | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Children will receive treatment everyday, twice a day as is: Amoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5 Amoxicillin Households - Antibiotic: Children in this arm will receive Amoxicillin twice a day. | 0 | None | 0 | 31 | 5 | 31 | View |
| Amoxicillin Households - Placebo | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Amoxicillin Households - Placebo: Children in this arm will receive Placebo. | 0 | None | 0 | 31 | 0 | 31 | View |
| Azithromycin Households - Antibiotic | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Children will receive treatment everyday, once a day as is: Azithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5 Azithromycin Households - Antibiotic: Children in this arm will receive Azithromycin once a day. | 0 | None | 0 | 31 | 3 | 31 | View |
| Azithromycin Households - Placebo | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Azithromycin Households - Placebo: Children in this arm will receive Placebo. | 0 | None | 0 | 31 | 5 | 31 | View |
| Cotrimoxazole Households - Antibiotic | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Children will receive treatment everyday, once a day as is: Co-trimoxazole: 240 mg daily for Days 1-5 Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day. Cotrimoxazole: Children in this arm will receive co-trimoxazole once a day. | 0 | None | 0 | 31 | 3 | 31 | View |
| Cotrimoxazole Households - Placebo | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. Cotrimoxazole Households - Placebo: Children in this arm will receive Placebo. | 0 | None | 0 | 31 | 3 | 31 | View |
| Placebo | Households were randomized in a 1:1:1:1 fashion to a 5-day course of amoxicillin, azithromycin, cotrimoxazole, or placebo. Within each antibiotic household, one child was randomly assigned to receive placebo. In placebo households, both children received placebo. | 0 | None | 0 | 60 | 7 | 60 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea, days 1-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cough, Days 1-5 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Vomiting, days 1-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever, days 1-5 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough, Day 9 | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Diarrhea, days 1-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea, day 9 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |