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 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
NCT ID:
NCT01663857
Description:
All participants who received at least one dose of drug.
Frequency Threshold:
5
Time Frame:
Up to 4.5 years
Study:
NCT01663857
Study Brief:
A Study LY2228820 for Recurrent Ovarian Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin | Cohort 1: LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6) Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10 Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3 Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+) | 3 | None | 3 | 6 | 6 | 6 | View |
| Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin | Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+) | 1 | None | 1 | 2 | 2 | 2 | View |
| Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin | Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+) | 30 | None | 26 | 58 | 58 | 58 | View |
| Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin | Arm B: Placebo orally every 12 hrs. on Days 1-10 Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+) | 31 | None | 12 | 52 | 52 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pelvic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Ureteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Urostomy complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Nuclear magnetic resonance imaging abdominal abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Drug reaction with eosinophilia and systemic symptoms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Anal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Adjustment disorder with depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.1 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Vulvovaginal pruritus | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Paranasal sinus discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Social problem | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 20.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.1 | View |