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 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
NCT ID:
NCT00833833
Description:
None
Frequency Threshold:
5
Time Frame:
Data cut-off 01 April 2011 Phase 1: up to 126 weeks Phase 2: up to 70 weeks
Study:
NCT00833833
Study Brief:
MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
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 1: 3 mg Pomalidomide | Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. | None | None | 4 | 8 | 8 | 8 | View |
| Phase 1: 4 mg Pomalidomide | Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. | None | None | 8 | 14 | 14 | 14 | View |
| Phase 1: 5 mg Pomalidomide | Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. | None | None | 4 | 10 | 10 | 10 | View |
| Phase 2: Pomalidomide + Dexamethasone | Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle. | None | None | 69 | 112 | 112 | 112 | View |
| Phase 2: Pomalidomide (Pom Only) | Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added. | None | None | 50 | 107 | 105 | 107 | View |
| Phase 2: Pomalidomide (Pom + Dex Only) | Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone. | None | None | 29 | 61 | 57 | 61 | View |
| Phase 2: Pomalidomide (Overall) | Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone. Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone. | None | None | 72 | 107 | 106 | 107 | View |
| Phase 1: 2 mg Pomalidomide | Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. | None | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia respiratory syncytial viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Arthritis baterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Herpes zoster disseminated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Herpes zoster ophthalmic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia parainfluenzae viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pseudomonas infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Arthritis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Lung infection pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Meningitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pharyngeal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Multiple myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Leukaemia plasmacytic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Metastases to meninges | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Catheter site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Hyperviscosity syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Caecitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Cardio-respiratory distress | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Brain mass | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Cauda equina syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Unresponsive to stimuli | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood culture positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.0) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| H1N1 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urethritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Arthritis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urinary tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Pruritus allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Hirsutism | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Ingrown nail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Lichenoid karatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Numb chin syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Post herpetic neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Heart rate irregular | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Affect lability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Eyelid disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Peripheral coldness | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.0) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.0) | View |
| Deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.0) | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (14.0) | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | View |
| Allergic oedema | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (14.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Feeling jittery | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Catheter site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Faecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Sensitivity of teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Hypoaesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Bone lesion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Bone infarction | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Polymyalgia rheumatica | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Sputum discoloured | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.0) | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.0) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.0) | View |