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 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
NCT ID:
NCT00121992
Description:
The safety analysis were conducted on all patients who started at least one infusion of the study treatment.
Frequency Threshold:
0
Time Frame:
Deaths were assessed for up to 10 years. Adverse Events were assessed for an average of 4 months
Study:
NCT00121992
Study Brief:
Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: FAC | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | 57 | None | 21 | 519 | 519 | 519 | View |
| Arm B: TAC | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide | 53 | None | 119 | 532 | 532 | 532 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Anal fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC version 1.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Blood bilirubin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Breast cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Breast infection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Breast haematoma | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Carotid artery thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC version 1.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI-CTC version 1.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC version 1.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NCI-CTC version 1.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTC version 1.0 | View |
| Fever in absence of infection | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC version 1.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI-CTC version 1.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTC version 1.0 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTC version 1.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI-CTC version 1.0 | View |
| Menstruation irregular | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI-CTC version 1.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Affective disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI-CTC version 1.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI-CTC version 1.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC version 1.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC version 1.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC v. 1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC version 1.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC version 1.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTC version 1.0 | View |
| Pigmentation disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTC version 1.0 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTC version 1.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI-CTC version 1.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTC v. 1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC version 1.0 | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTC version 1.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTC version 1.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTC version 1.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | View |