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 @ 9:47 PM
Ignite Modification Date: 2025-12-25 @ 7:26 PM
NCT ID: NCT02551432
Description: None
Frequency Threshold: 5
Time Frame: From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Study: NCT02551432
Study Brief: Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paclitaxel Pembrolizumab * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel 0 None 9 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
type 1 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Asthenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View