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 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
NCT ID:
NCT01617668
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01617668
Study Brief:
A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative 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 |
|---|---|---|---|---|---|---|---|---|
| LCL161+PACLITAXEL | Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm. | None | None | 45 | 106 | 106 | 106 | View |
| PACLITAXEL | Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm. | None | None | 7 | 103 | 101 | 103 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Atypical pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Polyarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Immobile | SYSTEMATIC_ASSESSMENT | Social circumstances | 17.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Neurotoxicity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Palmar-Plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |