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 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
NCT ID:
NCT00875433
Description:
None
Frequency Threshold:
5
Time Frame:
First administration of trial medication until 28 days after last administration of trial medication
Study:
NCT00875433
Study Brief:
Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| All Patients | Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd) | None | None | 34 | 60 | 58 | 60 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Nausea/Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Peritoneal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Rectal cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| Renal disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Renal insufficency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash/acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Ureteric obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ocular effect | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Nausea/Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Nail effect | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash/acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |