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 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
NCT ID:
NCT04502056
Description:
None
Frequency Threshold:
0
Time Frame:
31 days
Study:
NCT04502056
Study Brief:
Covid-19 Messaging to Underserved Communities - 2nd Experiment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention: AMA DP - B- B - N | Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color. African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos. AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted | 0 | None | 0 | 2052 | 0 | 2052 | View |
| Intervention: AMA RI - B- B - R | Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color . Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos. Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts | 0 | None | 0 | 2046 | 0 | 2046 | View |
| Intervention: AMA RI - B - B - N | Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will not include information on the disproportionate impact on communities of color. Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos. No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted | 0 | None | 0 | 2044 | 0 | 2044 | View |
| Intervention: AMA RI - W - W - R | Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color. Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video | 0 | None | 0 | 2045 | 0 | 2045 | View |
| Intervention: AMA RI - W - W - N | Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color. Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted | 0 | None | 0 | 2046 | 0 | 2046 | View |
| Intervention: AMA DP - B- B - R | Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - the message on Covid-19 will include information on the disproportionate impact on communities of color . African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA African American Sender in Informational Videos.: Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos. Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing | 0 | None | 0 | 2044 | 0 | 2044 | View |
| Intervention: AMA DP - W- W - R | Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will include information on the disproportionate impact on communities of color. Racial Inequality Highlighted: Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video | 0 | None | 0 | 2046 | 0 | 2046 | View |
| Intervention: AMA DP - W- W - N | Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will be white - the message on Covid-19 will not include information on the disproportionate impact on communities of color. AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing White Sender in Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement White Sender in Informational Videos: Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video No Racial Inequality Highlighting: In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted | 0 | None | 0 | 2043 | 0 | 2043 | View |
| Control: AMA RI - B - B | Respondents will be randomized to an AMA statement acknowledging racial injustice read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown. Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA | 0 | None | 0 | 1026 | 0 | 1026 | View |
| Control: AMA RI - W - W | Respondents will be randomized to an AMA statement acknowledging racial injustice read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown. Acknowledgement Racial Injustice AMA: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice. White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA | 0 | None | 0 | 1025 | 0 | 1025 | View |
| Control: AMA DP - B - B | Respondents will be randomized to an AMA statement acknowledging drug pricing read by an African American individual. The messenger / doctor in the follow-up AMA videos will also be African American - No message on Covid-19 will be shown. African American Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing | 0 | None | 0 | 1023 | 0 | 1023 | View |
| Control: AMA DP - W - W | Respondents will be randomized to an AMA statement acknowledging drug pricing read by a white individual. The messenger / doctor in the follow-up AMA videos will also be white - No message on Covid-19 will be shown. White Sender Acknowledgement: Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a white sender in acknowledgment of AMA AMA Acknowledgement Drug Pricing: Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing | 0 | None | 0 | 1020 | 0 | 1020 | View |
Serious Events(If Any):
Other Events(If Any):