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 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT01050634
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:
0
Time Frame:
None
Study:
NCT01050634
Study Brief:
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Observational | None | None | None | 11 | 924 | 82 | 924 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Brain neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Breast cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Tumour invasion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 12.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |
| Metastases to lymph nodes | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Menometrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Menopausal symptoms | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Vulvovaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| Menopause | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 12.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Arthritis reactive | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Nodal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Rheumatoid arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Metastases to lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Visual field defect | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Initial insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Thinking abnormal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Presbyacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |