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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT03609359
Description: The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
Frequency Threshold: 5
Time Frame: Basically 2 years, maximum 28 months
Study: NCT03609359
Study Brief: Lenvatinib and Pembrolizumab Simultaneous Combination Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lenvatinib + Pembrolizumab Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients. Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration. Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable). 15 None 4 29 29 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Caridiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastirc haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Livi disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysaethesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Prurtinis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Asparate amintransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood allkaline phosphatase incresed SYSTEMATIC_ASSESSMENT Investigations None View
Gastric stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ascities SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoalubuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View