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 @ 1:45 PM
Ignite Modification Date:
2025-12-25 @ 12:40 PM
NCT ID:
NCT01782495
Description:
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days after the last dose of study drug. TEAEs and TESAEs were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
Study:
NCT01782495
Study Brief:
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ARM B | Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | None | 1 | 27 | 27 | 27 | View |
| ARM C | Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. | 0 | None | 0 | 13 | 12 | 13 | View |
| ARM D | Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | None | 0 | 4 | 4 | 4 | View |
| ARM E | Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | None | 0 | 2 | 2 | 2 | View |
| ARM F | Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | None | 2 | 22 | 22 | 22 | View |
| ARM G | Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. | 0 | None | 1 | 12 | 12 | 12 | View |
| ARM H | Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 1 | None | 4 | 9 | 8 | 9 | View |
| ARM I | Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. | 0 | None | 0 | 3 | 3 | 3 | View |
| ARM J | Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | 0 | None | 0 | 2 | 2 | 2 | View |
| ARM K | Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | None | 0 | 1 | 1 | 1 | View |
| ARM A | Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. | 0 | None | 2 | 34 | 33 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| ISCHAEMIC CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| ATYPICAL PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| HAEMOLYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (20.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (20.0) | View |
| DIPLOPIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| EYE PRURITUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| OCULAR DISCOMFORT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| OCULAR HYPERAEMIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| VISUAL IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| VITREOUS FLOATERS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ANAL PRURITUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ANORECTAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| APHTHOUS ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| BOWEL MOVEMENT IRREGULARITY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DIVERTICULUM INTESTINAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| EPIGASTRIC DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| FAECES DISCOLOURED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| GINGIVAL BLEEDING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| LIP DRY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| OESOPHAGEAL DILATATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| TOOTH IMPACTED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| EXERCISE TOLERANCE DECREASED | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| FACE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| FEELING ABNORMAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| FEELING COLD | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| HERNIA PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| JAUNDICE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| ALLERGY TO ARTHROPOD BITE | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| LIVER TRANSPLANT REJECTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| SEASONAL ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.0) | View |
| ACARODERMATITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| CYTOMEGALOVIRUS VIRAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| FOLLICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| FUNGAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| HORDEOLUM | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| IMPETIGO | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| OTITIS MEDIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| PHARYNGITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| TINEA CRURIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| TINEA PEDIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| TOOTH INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| ARTHROPOD BITE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| ARTHROPOD STING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| EXCORIATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| JOINT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| MUSCLE STRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| POST-TRAUMATIC NECK SYNDROME | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| SCRATCH | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| SUNBURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| SUPERFICIAL INJURY OF EYE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| TOOTH FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| TRAUMATIC FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD BICARBONATE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD GLUCOSE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD POTASSIUM INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD UREA INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| BLOOD URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| CARDIAC MURMUR | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| CYTOMEGALOVIRUS TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| HAEMATOCRIT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| IMMUNOSUPPRESSANT DRUG LEVEL INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| VITAMIN D DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| DIABETES MELLITUS INADEQUATE CONTROL | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| GOUTY ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| GROIN PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| LIMB DISCOMFORT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MUSCLE FATIGUE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MUSCLE TWITCHING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MUSCULOSKELETAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| TENDONITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| KERATOACANTHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| BALANCE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| HYPERSOMNIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| MEMORY IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| ORTHOSTATIC INTOLERANCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| POOR QUALITY SLEEP | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| SINUS HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| TENSION HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| TUNNEL VISION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| ABNORMAL DREAMS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| AFFECT LABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| APATHY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| DEPRESSED MOOD | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| EMOTIONAL DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| LIBIDO INCREASED | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| MANIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| MOOD SWINGS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| NIGHTMARE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| RESTLESSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| ANURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| CHROMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| POLYURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| ERECTILE DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| GENITAL RASH | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| PENILE BLISTER | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| PROSTATOMEGALY | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| VULVOVAGINAL PRURITUS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| CHOKING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| DRY THROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| PARANASAL SINUS DISCOMFORT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| RESPIRATORY TRACT CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| SINUS CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| SNEEZING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| THROAT IRRITATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| UPPER RESPIRATORY TRACT CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| UPPER-AIRWAY COUGH SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| WHEEZING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| DERMATITIS CONTACT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| HAIR GROWTH ABNORMAL | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PETECHIAE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PHOTOSENSITIVITY REACTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PRURITUS GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| RASH PRURITIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| SKIN EXFOLIATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| SKIN LESION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| SKIN TIGHTNESS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |