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 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
NCT ID:
NCT01485861
Description:
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Frequency Threshold:
5
Time Frame:
Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
Study:
NCT01485861
Study Brief:
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
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 Ib: Ipatasertib 400 mg | Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity. | 1 | None | 9 | 14 | 14 | 14 | View |
| Phase Ib: Apitolisib 30 mg | Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity. | 0 | None | 5 | 6 | 6 | 6 | View |
| Phase II: Ipatasertib 400 mg + Abiraterone | Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity. | 67 | None | 43 | 84 | 82 | 84 | View |
| Phase II: Ipatasertib 200 mg + Abiraterone | Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity. | 71 | None | 42 | 88 | 79 | 88 | View |
| Phase II: Placebo + Abiraterone | Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity. | 68 | None | 18 | 81 | 76 | 81 | View |
| Safety Cohort: Ipatasertib 400 mg + Abiraterone | Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid. | 2 | None | 6 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ENTEROCOLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| FAECALOMA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| DIABETES MELLITUS INADEQUATE CONTROL | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| DIABETIC METABOLIC DECOMPENSATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| SMALL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1/23.1/25.1 | View |
| URETERIC OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| URETERIC STENOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| URETEROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| MULTIPLE FRACTURES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| ULNA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA18.1/23.1/25.1 | View |
| COAGULOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMOLYTIC URAEMIC SYNDROME | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA18.1/23.1/25.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| ATRIOVENTRICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| CARDIAC FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| LEFT VENTRICULAR FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.1/23.1/25.1 | View |
| CHORIORETINOPATHY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA18.1/23.1/25.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMATOCHEZIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| PHARYNGO-OESOPHAGEAL DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| SPINAL CORD INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| ACCIDENTAL OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| SKULL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| HAEMATOCRIT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| KETOACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMATOMA MUSCLE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| OSTEOLYSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| SPINAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1/23.1/25.1 | View |
| PROSTATIC ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1/23.1/25.1 | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1/23.1/25.1 | View |
| CEREBRAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| NERVOUS SYSTEM DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| VASCULAR ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| BLADDER PERFORATION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| CALCULUS URINARY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| NEPHROPATHY TOXIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| RENAL COLIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA18.1/23.1/25.1 | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA18.1/23.1/25.1 | View |
| ACUTE PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| INTERSTITIAL LUNG DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| TOXIC SKIN ERUPTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| AORTIC ANEURYSM RUPTURE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| PELVIC VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| MALNUTRITION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| DECUBITUS ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| BLOOD URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOVOLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| INCREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| RESTLESSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERTONIC BLADDER | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| RENAL PAIN | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| PENILE PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| SINUS CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| WHEEZING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| ECCHYMOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMORRHAGE SUBCUTANEOUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| ONYCHOLYSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| TASTE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.1/23.1/25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| PAIN IN JAW | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.1/23.1/25.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.1/23.1/25.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA18.1/23.1/25.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.1/23.1/25.1 | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA18.1/23.1/25.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| DRY THROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA18.1/23.1/25.1 | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA18.1/23.1/25.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.1/23.1/25.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.1/23.1/25.1 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA18.1/23.1/25.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ORAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA18.1/23.1/25.1 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ERUCTATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| RETCHING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| TONGUE DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| THIRST | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.1/23.1/25.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| FUNGAL URETHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.1/23.1/25.1 | View |
| MENISCUS INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.1/23.1/25.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA18.1/23.1/25.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| CHEILOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.1/23.1/25.1 | View |