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: 2025-12-24 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT04015232
Description: None
Frequency Threshold: 0
Time Frame: 99 Days
Study: NCT04015232
Study Brief: Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
INTP5 Biosimilar Product INTP5 subcutaneously at a dose of 6 mg/0.6 mL. INTP5: A pegfilgrastim biosimilar to US Neulasta. 0 None 0 100 32 100 View
US Neulasta Reference Product US Neulasta subcutaneously at a dose of 6 mg/0.6 mL. US Neulasta: FDA approved pegfilgrastim innovator product. 1 None 1 100 37 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Human chorionic gonadotropin increased SYSTEMATIC_ASSESSMENT Investigations None View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations None View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urine abnormality SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View