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: 2025-12-25 @ 1:14 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT02282293
Description: None
Frequency Threshold: 0
Time Frame: Following administration of first study drug to 6 weeks postpartum
Study: NCT02282293
Study Brief: Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TS + DP Placebo Pregnancy Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Placebo 0 None 4 100 92 100 View
Daily TS + Monthly DP Pregnancy Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily. Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines. Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy Monthly dihydroartemisinin-piperaquine (DP) for infants 0 None 6 100 91 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Congenital anomaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated ALT level SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Stillbirth SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View