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 @ 9:50 PM
Ignite Modification Date: 2025-12-25 @ 7:28 PM
NCT ID: NCT00896532
Term: Colitis ischaemic
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 18.1
Notes: None
Study: NCT00896532
Study Brief: Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG005 None 0 52 View
EG013 None 1 52 View
EG017 None 0 18 View
EG021 None 0 90 View
EG000 None 0 30 View
EG001 None 0 20 View
EG002 None 0 51 View
EG003 None 0 54 View
EG004 None 0 50 View
EG006 None 0 49 View
EG007 None 0 53 View
EG008 None 0 51 View
EG009 None 0 30 View
EG010 None 0 20 View
EG011 None 0 51 View
EG012 None 0 50 View
EG014 None 0 49 View
EG015 None 0 53 View
EG016 None 0 51 View
EG018 None 0 17 View
EG019 None 0 19 View
EG020 None 0 19 View
EG022 None 0 89 View
EG023 None 0 12 View
EG024 None 0 15 View
EG025 None 0 72 View
EG026 None 0 68 View
EG027 None 0 51 View
EG028 None 0 3 View
EG029 None 0 11 View
EG030 None 0 12 View
EG031 None 0 56 View
EG032 None 0 8 View