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 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
NCT ID:
NCT02495233
Description:
Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.
Frequency Threshold:
0
Time Frame:
From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Study:
NCT02495233
Study Brief:
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Gilteritinib 80mg+ Erlotinib 150mg | Gilteritinib was administered in combination with erlotinib orally once daily. | 0 | None | 3 | 7 | 7 | 7 | View |
| Gilteritinib 120mg + Erlotinib 150mg | Gilteritinib was administered in combination with erlotinib orally once daily. | 0 | None | 2 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | None | Investigations | MedDRA 17.1 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA 17.1 | View |
| Fracture | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA 17.1 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Enteritis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Gastric disorder | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Haemorrhoids | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Toothache | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA 17.1 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA 17.1 | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA 17.1 | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA 17.1 | View |
| Blood creatinine increased | None | Investigations | MedDRA 17.1 | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA 17.1 | View |
| Aldolase increased | None | Investigations | MedDRA 17.1 | View |
| Amylase increased | None | Investigations | MedDRA 17.1 | View |
| Electrocardiogram QT prolonged | None | Investigations | MedDRA 17.1 | View |
| Myoglobin blood increased | None | Investigations | MedDRA 17.1 | View |
| Platelet count decreased | None | Investigations | MedDRA 17.1 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Paronychia | None | Infections and infestations | MedDRA 17.1 | View |
| Acne pustular | None | Infections and infestations | MedDRA 17.1 | View |
| Conjunctivitis | None | Infections and infestations | MedDRA 17.1 | View |
| Cystitis | None | Infections and infestations | MedDRA 17.1 | View |
| Gastroenteritis staphylococcal | None | Infections and infestations | MedDRA 17.1 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 17.1 | View |
| Skin infection | None | Infections and infestations | MedDRA 17.1 | View |
| Hypoalbuminaemia | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Hypophosphataemia | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 17.1 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA 17.1 | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | MedDRA 17.1 | View |
| Headache | None | Nervous system disorders | MedDRA 17.1 | View |
| Peripheral motor neuropathy | None | Nervous system disorders | MedDRA 17.1 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Hiccups | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Fatigue | None | General disorders | MedDRA 17.1 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 17.1 | View |
| Sinus tachycardia | None | Cardiac disorders | MedDRA 17.1 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Cancer pain | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| Tumour pain | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 17.1 | View |
| Proteinuria | None | Renal and urinary disorders | MedDRA 17.1 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 17.1 | View |
| Hypertension | None | Vascular disorders | MedDRA 17.1 | View |
| Oral dysaesthesia | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Weight decreased | None | Investigations | MedDRA 17.1 | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Pleurisy | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Malaise | None | General disorders | MedDRA 17.1 | View |