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 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
NCT ID:
NCT01823835
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 3 years
Study:
NCT01823835
Study Brief:
A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive 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 |
|---|---|---|---|---|---|---|---|---|
| Phase Ia - Cohort 1 | 100 mg GDC-0810 once daily (QD) in fasting state. | 1 | None | 1 | 3 | 3 | 3 | View |
| Phase Ia - Cohort 2 | 200 mg GDC-0810 QD in fasting state. | 1 | None | 1 | 4 | 4 | 4 | View |
| Phase Ia - Cohort 3 | 400 mg GDC-0810 QD in fasting state. | 0 | None | 1 | 4 | 4 | 4 | View |
| Phase Ia - Cohort 4 | 600 mg GDC-0810 QD in fasting state. | 1 | None | 1 | 6 | 6 | 6 | View |
| Phase Ia - Cohort 5 | 600 mg GDC-0810 QD in non-fasting state. | 2 | None | 3 | 6 | 6 | 6 | View |
| Phase Ia - Cohort 6 | 300 mg GDC-0810 twice daily (BID) in fasting state. | 0 | None | 4 | 6 | 6 | 6 | View |
| Phase Ia - Cohort 7 | 800 mg GDC-0810 QD in fasting state. | 1 | None | 1 | 6 | 6 | 6 | View |
| Phase Ia - Cohort 8 | 800 mg GDC-0810 QD in non-fasting state. | 0 | None | 1 | 3 | 3 | 3 | View |
| Phase Ia - Cohort 9 | 400 mg GDC-0810 BID in fasting state. | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase IIa - Cohort A1 | 600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD). | 0 | None | 4 | 19 | 18 | 19 | View |
| Phase IIa - Cohort A2 | 600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD. | 0 | None | 1 | 10 | 10 | 10 | View |
| Phase IIa - Cohort B1 | 600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI). | 3 | None | 11 | 53 | 51 | 53 | View |
| Phase IIa - Cohort B2 | 600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI. | 0 | None | 1 | 19 | 19 | 19 | View |
| Phase Ib - Cohort C1 | 400 mg GDC-0810 + 125 mg Palbociclib QD. | 0 | None | 1 | 4 | 4 | 4 | View |
| Phase Ib - Cohort D1 | ≤600 mg GDC-0810 QD + LHRH agonist once monthly. | 0 | None | 2 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| CARDIAC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| HEPATIC HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 23.0 | View |
| APPENDICITIS PERFORATED | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| HIP FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| BREAST CANCER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | View |
| TUMOUR PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| SEIZURE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| SYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| HYDRONEPHROSIS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| ENDOMETRIAL HYPERPLASIA | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| PULMONARY EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| ADRENAL INSUFFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 23.0 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DISEASE PROGRESSION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| BLOOD BILIRUBIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| DEVICE DISLOCATION | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA version 23.0 | View |
| PNEUMOTHORAX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| VENOUS THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| LYMPHOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| THROMBOCYTOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23.0 | View |
| ANGINA PECTORIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| PALPITATIONS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| SINUS TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| BLEPHARITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| DRY EYE | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| EYELID PTOSIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| VISION BLURRED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| ABDOMINAL DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ABDOMINAL DISTENSION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ABDOMINAL PAIN LOWER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| COLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DRY MOUTH | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| DYSPHAGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ERUCTATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| FLATULENCE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| GASTROINTESTINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| HAEMORRHOIDAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| HAEMORRHOIDS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| CHEST DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| GAIT DISTURBANCE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| IMPAIRED HEALING | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| MALAISE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| MUCOSAL INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| SWELLING | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| SWELLING FACE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| TENDERNESS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| CELLULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| HERPES ZOSTER | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| LOCALISED INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| ORAL HERPES | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| SKIN INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| STAPHYLOCOCCAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| TOOTH INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| VAGINAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| VULVOVAGINAL MYCOTIC INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| CONTUSION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| PELVIC FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD CREATININE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD URIC ACID INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| LIVER FUNCTION TEST INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| TRANSAMINASES INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| WHITE BLOOD CELL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERGLYCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERTRIGLYCERIDAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOALBUMINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOPHOSPHATAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| BONE PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| FLANK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MUSCLE SPASMS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MUSCULAR WEAKNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MUSCULOSKELETAL CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MUSCULOSKELETAL STIFFNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| NECK MASS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| OSTEONECROSIS OF JAW | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| PAIN IN JAW | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| SPINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| METASTASIS | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | View |
| ATAXIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| DYSGEUSIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| HYPERSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| MEMORY IMPAIRMENT | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| MIGRAINE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| NEUROPATHY PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| PARAESTHESIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| TASTE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| VOCAL CORD PARALYSIS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| MOOD SWINGS | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| SUICIDAL IDEATION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| ACUTE KIDNEY INJURY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| DYSURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| MICTURITION URGENCY | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| URINARY RETENTION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| URINARY TRACT PAIN | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| BREAST ATROPHY | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| BREAST PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| ENDOMETRIAL THICKENING | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| OEDEMA GENITAL | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| PELVIC PAIN | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| VAGINAL DISCHARGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| DRY THROAT | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| DYSPNOEA EXERTIONAL | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| HAEMOPTYSIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| OROPHARYNGEAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| PRODUCTIVE COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| PULMONARY EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| UPPER-AIRWAY COUGH SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| WHEEZING | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| BLISTER | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| PAPULE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| RASH MACULO-PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| SKIN ULCER | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| URTICARIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| FLUSHING | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| HAEMATOMA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| HOT FLUSH | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| PALLOR | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |
| PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| SINUS BRADYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 23.0 | View |
| EAR PAIN | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 23.0 | View |
| EXTERNAL EAR PAIN | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 23.0 | View |
| TINNITUS | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 23.0 | View |
| IDIOPATHIC ORBITAL INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| LACRIMATION INCREASED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| PHOTOPSIA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 23.0 | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| FAECES SOFT | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| GASTROINTESTINAL INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| GINGIVAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| GINGIVAL SWELLING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| LIP SWELLING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| ORAL MUCOSAL ERUPTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| PANCREATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23.0 | View |
| FACIAL PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23.0 | View |
| BREAST CELLULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| CROUP INFECTIOUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| DIVERTICULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| EYE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| FUNGAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| FURUNCLE | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| GASTROENTERITIS NOROVIRUS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| GINGIVITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| HELICOBACTER INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| ORAL CANDIDIASIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| OTITIS EXTERNA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| WOUND INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23.0 | View |
| ARTHROPOD BITE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| HAND FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| MUSCLE STRAIN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| PROCEDURAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| RIB FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| SKIN LACERATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| SPINAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| WOUND | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23.0 | View |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| AMYLASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BILIRUBIN CONJUGATED INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD ALKALINE PHOSPHATASE DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD BILIRUBIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD CHLORIDE DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD CHOLESTEROL INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD PHOSPHORUS INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD THYROID STIMULATING HORMONE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| BLOOD URINE PRESENT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| CRYSTAL URINE PRESENT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| GLUCOSE URINE PRESENT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| HIGH DENSITY LIPOPROTEIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| HIGH DENSITY LIPOPROTEIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| LOW DENSITY LIPOPROTEIN INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| LYMPHOCYTE COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| NEUTROPHIL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| NEUTROPHIL COUNT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| NITRITE URINE PRESENT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| PLATELET COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| RED BLOOD CELL COUNT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| RED BLOOD CELLS URINE POSITIVE | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| URINARY CASTS PRESENT | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| WHITE BLOOD CELL COUNT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 23.0 | View |
| HYPERCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERPROTEINAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPERURICAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOCHLORAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOGLYCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 23.0 | View |
| GROIN PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| JOINT STIFFNESS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | View |
| LETHARGY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| SCIATICA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 23.0 | View |
| IRRITABILITY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| MOOD ALTERED | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 23.0 | View |
| PROTEINURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| RENAL DISORDER | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| URINARY TRACT DISORDER | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 23.0 | View |
| DYSPAREUNIA | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| UTERINE POLYP | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| VAGINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| VULVOVAGINAL DRYNESS | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 23.0 | View |
| ASTHMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| HYPOXIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| PLEURAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| RHINORRHOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | View |
| ACNE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| ERYTHEMA MULTIFORME | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| LICHEN SCLEROSUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| MACULE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| MADAROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| PAIN OF SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| RASH ERYTHEMATOUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | View |
| LYMPHOEDEMA | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23.0 | View |