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 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
NCT ID:
NCT02047318
Description:
After a short dose escalation period (at dose levels less than 280 ug/kg/day), participants received MRX 280 ug/kg/day. An increase to BID dosing up to 560 mcg/kg/day was permitted during the long-term extension. The majority of exposure within the study was at 280 mcg/kg/day. 4 participants started on 140 mcg/kg/day or higher but had a dose interruption and went through dose escalation from 35 mcg/kg/day up to 280 mcg/kg/day. Thus, the counts for AE are higher than the core period.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events are AEs with a start date on or after the first dose of study drug and with a start date prior to the last dose of study drug plus 14 days. Maximum exposure was 336 weeks.
Study:
NCT02047318
Study Brief:
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 14 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated starting at 14 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 14 mcg/kg/day. | 0 | None | 0 | 6 | 3 | 6 | View |
| 35 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 14 to 35 for one week. This reporting group includes the period of time that participants received 35 mcg/kg/day. | 0 | None | 0 | 10 | 6 | 10 | View |
| 70 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 35 to 70 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 70 mcg/kg/day. | 0 | None | 1 | 10 | 3 | 10 | View |
| 140 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 70 to 140 microgram per kilogram per day (mcg/kg/day) for one week. This reporting group includes the period of time that participants received 140 mcg/kg/day. | 0 | None | 0 | 13 | 10 | 13 | View |
| 280 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 140 to 280 microgram per kilogram per day (mcg/kg/day) for 8-week dose optimization period and during the stable dosing period for up to 124 weeks. Participants who received MRX in the predecessor study LUM001-302 started on their dose from Week 13 of that study (280 mcg/kg/day or highest tolerated dose). This reporting group includes the period of time that participants received 280 mcg/kg/day. | 0 | None | 6 | 19 | 18 | 19 | View |
| 420 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Based on efficacy and safety assessments, participants could receive BID dosing after week 136, starting at 420 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. This reporting group includes the period of time that participants received 420 mcg/kg/day. | 0 | None | 0 | 5 | 3 | 5 | View |
| 560 Microgram Per Kilogram Per Day (mcg/kg/Day) | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants on BID dosing could have their dose escalated from 480 to 560 microgram per kilogram per day (mcg/kg/day) for the remainder of the study. This reporting group includes the period of time that participants received 560 mcg/kg/day. | 0 | None | 1 | 5 | 5 | 5 | View |
| LUM001 MRX Treatment | Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 14, 35, 70, and 140 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. Participants who received maralixibat during study LUM001-302, underwent a mock dose escalation and remained on the dose received at the end of study LUM001-302. During 8-weeks of dose optimization period, drug was adjusted in titrated manner up to 280 mcg/kg/day or highest tolerated dose and dosing was continued to complete the stable dosing and safety monitoring periods for up to 136 weeks of cumulative MRX exposure in this study at this dose level. In the long-term extension, participants could receive BID dosing up to 560 mcg/kg/day for the remainder of the study for up to 336 weeks of cumulative MRX exposure in this study. This reporting group includes all doses of MRX. | 0 | None | 6 | 19 | 18 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v.22.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v.22.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v.22.1 | View |
| Ear haemorrhage | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v.22.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Gastrointestinal stoma output decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v.22.1 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Fibrinous bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Medical device change | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v.22.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v.22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stress fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Vaccination complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v.22.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v.22.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v.22.1 | View |
| Ear pruritus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v.22.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Abnormal faeces | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Chapped lips | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Lip haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Malabsorption | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Mouth haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v.22.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v.22.1 | View |
| Biliary tract disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v.22.1 | View |
| Hepatic lesion | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v.22.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v.22.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v.22.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Epstein-Barr virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Hepatitis infectious mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v.22.1 | View |
| Anaemia postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Drain site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Limb crushing injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Post procedural fever | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Stoma site erythema | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Stoma site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Wound haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v.22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Bilirubin urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Blood parathyroid hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Intracardiac pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Urobilinogen urine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Vitamin D decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Vitamin E decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v.22.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v.22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Bone metabolism disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v.22.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Poor quality sleep | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v.22.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v.22.1 | View |
| Breath holding | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v.22.1 | View |
| Enuresis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v.22.1 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v.22.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v.22.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v.22.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v.22.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v.22.1 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v.22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Fibrinous bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v.22.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Xanthelasma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v.22.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v.22.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v.22.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v.22.1 | View |