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 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
NCT ID:
NCT00717405
Description:
None
Frequency Threshold:
5
Time Frame:
From Baseline until end of study (Up to approximately 6 years)
Study:
NCT00717405
Study Brief:
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast 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 |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab + Trastuzumab | Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m\^2 IV 5-fluorouracil, 100 mg/m\^2 IV epirubicin, and 500 mg/m\^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m\^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative \[neoadjuvant + adjuvant\] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive. | None | None | 20 | 52 | 52 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Ejection fraction decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Metrorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (16.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Jugular vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Atrial tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Tooth loss | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Incision site abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Nasal septum perforation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Febrile bone marrow aplasia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Spinal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Lymphocele | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.1) | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gingival bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Oral fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Radiation skin injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Ageusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (16.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Nail toxicity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Skin toxicity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (16.1) | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Lymphocele | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Ejection fraction decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Rectal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |