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 @ 4:28 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
NCT ID: NCT02968420
Description: Provincially reportable and serious adverse events only were collected.
Frequency Threshold: 0
Time Frame: Adverse events were collected at Day 7 (+/-1) and Day 30 (+/-3) following booster dose.
Study: NCT02968420
Study Brief: Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. 0 None 0 6 0 6 View
Group 2 Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. 0 None 0 6 0 6 View
Group 3 Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):