Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT00553358
Description:
None
Frequency Threshold:
2
Time Frame:
Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
Study:
NCT00553358
Study Brief:
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
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 1000/750 mg + Trastuzumab 2 mg/kg | Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks | 1 | None | 61 | 149 | 147 | 149 | View |
| Lapatinib 1500 mg | Oral lapatinib (1500 milligrams \[mg\] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared \[mg/m\^2\]) intravenous (IV) for an additional 12 weeks | 2 | None | 58 | 151 | 148 | 151 | View |
| Trastuzumab 2 mg/kg | Trastuzumab (4 mg/kilograms \[kg\] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m\^2 IV) for an additional 12 weeks | 0 | None | 36 | 148 | 141 | 148 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| BACTERIAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| BREAST CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| CELLULITIS STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| DEVICE RELATED SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| HEPATITIS B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| MASTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| ACCIDENTAL OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| SEROMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| TOXICITY TO VARIOUS AGENTS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| TRANSFUSION REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPERPHOSPHATASAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| OSTEOPOROTIC FRACTURE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| LOBULAR BREAST CARCINOMA IN SITU | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | View |
| UTERINE LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| NEPHRECTASIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| METRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| VULVOVAGINAL PRURITUS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| INTERSTITIAL LUNG DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| ORGANISING PNEUMONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| BLISTER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| JUGULAR VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| GASTRITIS EROSIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| HYPERTRANSAMINASAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| ENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| AGRANULOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| DUODENITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| HEPATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.0) | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.0) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.0) | View |
| LACRIMATION INCREASED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.0) | View |
| VISUAL IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.0) | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ANAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| EPIGASTRIC DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| AXILLARY PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| FACE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| FEELING COLD | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| GENERALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| MUCOSAL DRYNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| MUCOSAL EROSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| HYPERTRANSAMINASAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.0) | View |
| SEASONAL ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.0) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| MASTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| NAIL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| PUSTULE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| TONSILLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| VAGINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| RADIATION SKIN INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| SEROMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| THERMAL BURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| WOUND COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| EJECTION FRACTION DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| NEUTROPHIL COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPERPHOSPHATASAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| JOINT STIFFNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| MUSCULOSKELETAL STIFFNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| OSTEOPOROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| AGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| MEMORY IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| NEUROTOXICITY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| TASTE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.0) | View |
| AMENORRHOEA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| BREAST DISCHARGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| BREAST PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| MENSTRUATION IRREGULAR | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| VULVOVAGINAL DRYNESS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| VULVOVAGINAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| VULVOVAGINAL PRURITUS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| NASAL DRYNESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| NASAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| DERMATITIS ACNEIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| EXFOLIATIVE RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| NAIL DISORDER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| NAIL DYSTROPHY | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| ONYCHALGIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| ONYCHOLYSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| PAIN OF SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| RASH PRURITIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SCAR PAIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN EXFOLIATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN FISSURES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN HYPERPIGMENTATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN IRRITATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN LESION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| SKIN REACTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| LYMPHOEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| PHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |