Serious Event

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: 2025-12-25 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT02658734
Term: METASTATIC NEOPLASM
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA version 22.1
Notes: None
Study: NCT02658734
Study Brief: A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 70 View