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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
NCT ID:
NCT04945733
Description:
The safety analysis set included all participants who took at least 1 dose of study treatment.
Frequency Threshold:
5
Time Frame:
All-cause mortality: From screening up to 30 days after last dose of study drug (up to 10 months); Serious AEs and Other AEs: From start of the treatment (Day 1) up to 30 days after last dose of study drug (up to 9 months)
Study:
NCT04945733
Study Brief:
A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal 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 |
|---|---|---|---|---|---|---|---|---|
| Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 5 | None | 9 | 29 | 28 | 29 | View |
| Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight \<80 kg or 2100 mg for body weight \>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight \<80 kg or 1750 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight \<80 kg or 1400 mg for body weight \>=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg or 1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 2 | None | 7 | 30 | 30 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 26.0 | View |
| Adrenal Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 26.0 | View |
| Gastrointestinal Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Oesophageal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Disease Progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Bile Duct Stenosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Retroperitoneal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Kidney Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Radiation Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Eastern Cooperative Oncology Group Performance Status Worsened | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Tumour Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | View |
| Interstitial Lung Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Tracheal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Decubitus Ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Dermatitis Acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Skin Fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.0 | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Hepatic Function Abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.0 | View |
| Liver Disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.0 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |
| Eastern Cooperative Oncology Group Performance Status Worsened | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | View |
| Cancer Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 26.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 26.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.0 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.0 | View |