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 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
NCT ID:
NCT00667251
Description:
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 165 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 166 months.
Study:
NCT00667251
Study Brief:
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic 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 |
|---|---|---|---|---|---|---|---|---|
| Lapatinib (LTax/L) - All Participants | Lapatinib (LTax/L) - All participants: Events up to 28 days post-treatment | 21 | None | 106 | 322 | 316 | 322 | View |
| Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | Lapatinib (LTax/L) - Crossed over to Trastuzumab (TTax/T) after IA results: Events up to 28 days post-treatment | 0 | None | 2 | 5 | 1 | 5 | View |
| Lapatinib (LTax/L) - All Participants (Post-treatment) | Lapatinib (LTax/L) - All participants (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events. | 82 | None | 0 | 0 | 0 | 0 | View |
| Trastuzumab (TTax/T) (Post-treatment) | Trastuzumab (TTax/T) (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events. | 73 | None | 0 | 0 | 0 | 0 | View |
| Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results (Post-treatment) | Lapatinib (LTax/L) - Crossed over to Trastuzumab (TTax/T) after IA results: Deaths in the post-treatment survival follow-up were not considered adverse events. | 0 | None | 0 | 0 | 0 | 0 | View |
| Trastuzumab (TTax/T) | Trastuzumab (TTax/T): Events up to 28 days post-treatment | 13 | None | 66 | 325 | 319 | 325 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Right ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (25.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (25.1) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (25.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Fistula of small intestine | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrointestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Large intestine infection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Oesophageal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Small intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Hepatobiliary disease | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (25.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Upper aerodigestive tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Gastrointestinal anastomotic leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Alanine aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Aspartate aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Blood bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Blood creatinine | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Haemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Lipase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Neutrophil count | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Musculoskeletal disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Multifocal motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Sexual dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Uterine haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Platelet disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (25.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Gamma-glutamyltransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Multifocal motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |