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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MLN2480 200 mg + Paclitaxel 80 mg/m^2 | Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m\^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care. | 0 | None | 2 | 4 | 4 | 4 | View |
| MLN2480 400 mg + Paclitaxel 80 mg/m^2 | Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m\^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care. | 0 | None | 3 | 6 | 6 | 6 | View |
| MLN2480 100 mg + MLN0128 2 mg | Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and MLN0128 2 mg, capsules, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles. | 0 | None | 2 | 4 | 4 | 4 | View |
| MLN2480 100 mg + Alisertib 30 mg | Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle. | 0 | None | 1 | 3 | 3 | 3 | View |
| MLN2480 160 mg + Alisertib 30 mg | Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, twice daily (BID) on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle. | 2 | None | 5 | 7 | 7 | 7 | View |
| MLN2480 200 mg + Alisertib 30 mg | Dose Escalation Phase: MLN2480 200 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 30 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle. | 0 | None | 1 | 3 | 3 | 3 | View |
| MLN2480 100 mg + Alisertib 40 mg | Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and alisertib 40 mg, tablets, orally, BID on protocol specified days of a 28-day cycle for up to 12 cycles. The doses of MLN2480 and alisertib were modified during this phase based on tolerability during each 28-day cycle. | 1 | None | 3 | 8 | 8 | 8 | View |
| MLN2480 100 mg + Paclitaxel 80 mg/m^2 | Dose Escalation Phase: MLN2480 100 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 milligram per square meter (mg/m\^2), intravenous (IV) infusion, once weekly (QW) for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care. | 0 | None | 1 | 4 | 4 | 4 | View |
| MLN2480 160 mg + Paclitaxel 80 mg/m^2 | Dose Escalation Phase: MLN2480 160 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m\^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care. | 0 | None | 1 | 3 | 3 | 3 | View |
| MLN2480 600 mg + Paclitaxel 80 mg/m^2 | Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m\^2, IV infusion, QW for 3 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in paclitaxel dose was based on the standard of care. | 0 | None | 4 | 8 | 8 | 8 | View |
| MLN2480 400 mg + Cetuximab 250 mg/m^2 | Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m\^2 (cycle 1 Day 1), then at 250 mg/m\^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care. | 2 | None | 2 | 6 | 6 | 6 | View |
| MLN2480 600 mg + Cetuximab 250 mg/m^2 | Dose Escalation Phase: MLN2480 600 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and cetuximab administered intravenously at a loading dose of 400 mg/m\^2 (cycle 1 Day 1), then at 250 mg/m\^2 QW on Days 8, 15, and 22 of cycle 1 and Days 1, 8, 15, and 22 in each additional 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in cetuximab dose was based on the standard of care. | 2 | None | 3 | 7 | 7 | 7 | View |
| ML2480 300 mg + Irinotecan 180 mg/m^2 | Dose Escalation Phase: MLN2480 300 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m\^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care. | 0 | None | 0 | 1 | 1 | 1 | View |
| ML2480 400 mg + Irinotecan 180 mg/m^2 | Dose Escalation Phase: MLN2480 400 mg, tablets, orally, once on protocol specified days of a 28-day cycle for up to 12 cycles, and irinotecan 180 mg/m\^2, IV infusion over 90 minutes, every other week (Q2W) for 2 weeks in each 28-day cycle for up to 12 cycles. The dose of MLN2480 was modified during this phase based on tolerability during each 28-day cycle. Any changes in irinotecan dose was based on the standard of care. | 0 | None | 4 | 7 | 7 | 7 | View |
| Dose Expansion: MLN2480 600 mg + Paclitaxel 80 mg/m^2 | Dose Expansion Phase: MLN2480 600 mg, tablets, orally, once per week on Days 2, 9, 16 and 23 of a 28-day cycle for up to 12 cycles, and paclitaxel 80 mg/m\^2, IV infusion, once on 1, 8, and 15 of a 28-day cycle for up to 12 cycles. | 2 | None | 7 | 10 | 10 | 10 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Colorectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Gastrointestinal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Metastatic malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Splenic haemorrhage | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Bile duct obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Post-tussive vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Gastrointestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Oesophagitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Faecal vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Glossitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Mouth haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Tongue coated | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Administration site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Catheter site oedema | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Unevaluable event | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Vaccination site reaction | SYSTEMATIC_ASSESSMENT | General disorders | 20.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Ephelides | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Hair colour changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Onycholysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Pigmentation disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Systemic lupus erythematosus rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Oropharyngeal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Painful respiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 20.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 20.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Vitamin D decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Adjusted calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood magnesium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Breath sounds abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Clubbing | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Fibromyalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Hyperaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Motor dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Neurotoxicity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Breast abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Conjunctivitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Infective exacerbation of chronic obstructive airways disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Tongue fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 20.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Pallor | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Vena cava thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 20.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Eye inflammation | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | 20.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Atrial thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Renal hypertension | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 20.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 20.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 20.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Metastases to skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 20.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 20.0 | View |
| Thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 20.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Incision site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Stoma site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 20.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 20.0 | View |
| Female genital tract fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 20.0 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 20.0 | View |
| Vulvovaginal discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 20.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 20.0 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 20.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |
| Keratosis pilaris | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Miliaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Nodular rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 20.0 | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Prothrombin level decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Peripheral sensorimotor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 20.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 20.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 20.0 | View |
| Hypopituitarism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 20.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 20.0 | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | 20.0 | View |
| Deafness unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 20.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 20.0 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | 20.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | 20.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 20.0 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 20.0 | View |