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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT00337818
Description: Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
Frequency Threshold: 5
Time Frame: During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Study: NCT00337818
Study Brief: Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cervarix New Process Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process. None None 11 186 0 0 View
Cervarix Young Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process. None None 3 57 0 0 View
Cervarix Old Process Group Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process. None None 3 65 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Premature separation of placenta NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Enteritis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blighted ovum NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Chorioamnionitis NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stillbirth NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anogenital warts NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):