Serious Event

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Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event

Ignite Creation Date: 2025-12-24 @ 1:43 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT02561195
Term: Cholecystitis
Organ System: Hepatobiliary disorders
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Study: NCT02561195
Study Brief: A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 0 182 View
EG002 None 0 61 View
EG003 None 1 183 View
EG005 None 0 61 View
EG006 None 0 16 View
EG008 None 0 24 View
EG009 None 0 22 View
EG011 None 0 52 View
EG012 None 0 58 View
EG001 None 0 184 View
EG004 None 0 183 View
EG007 None 0 18 View
EG010 None 0 51 View
EG013 None 0 59 View