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 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
NCT ID:
NCT04109066
Description:
The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.
Frequency Threshold:
5
Time Frame:
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).
Study:
NCT04109066
Study Brief:
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary 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 |
|---|---|---|---|---|---|---|---|---|
| Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET | Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + AC Q3W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET) | 8 | None | 38 | 127 | 126 | 127 | View |
| Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET | Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W): Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET) | 7 | None | 51 | 135 | 132 | 135 | View |
| Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET | Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + AC Q3W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET) | 4 | None | 20 | 123 | 120 | 123 | View |
| Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET | Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W): Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET) | 4 | None | 26 | 132 | 130 | 132 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myelosuppression | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Cardiac perfusion defect | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Hypopituitarism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Immune-mediated adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Thyroiditis subacute | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Hepatitis cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Breast cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Mastitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumocystis jirovecii infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| SARS-CoV-2 sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Systemic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Vascular access site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Craniofacial fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Radiation skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Surgical procedure repeated | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Inflammatory marker increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Cervix carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Cerebellar syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Guillain-Barre syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Intracranial pressure increased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | 26.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | 26.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Glomerulonephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Breast inflammation | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Immune-mediated lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Pemphigoid | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Arterial thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Illness | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Radiation skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood calcium increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood thyroid stimulating hormone decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Onycholysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 26.1 | View |