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 @ 4:45 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT01706250
Description: ITT Population. There were no treatment -related adverse events reported during the study, so the data has been reported as an overall, single arm; as the participants used were the same in each arm
Frequency Threshold: 0
Time Frame: From the informed consent taken to up to 4 months
Study: NCT01706250
Study Brief: U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MAXCLARITY II + PROACTIV This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion. 0 None 0 20 5 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View