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 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
NCT ID:
NCT00735904
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00735904
Study Brief:
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-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 |
|---|---|---|---|---|---|---|---|---|
| Axitinib + Cisplatin + Gemcitabine | Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m\^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m\^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase. | None | None | 15 | 38 | 34 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Hemiplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pulmonary artery thrombosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Lung abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Creatinine renal clearance decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Nephropathy toxic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pulmonary cavitation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |