Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (NCT NCT03047395)
NCT ID: NCT03047395
Last Updated: 2024-12-11
Results Overview
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2170 participants
Primary outcome timeframe
Median follow-up time of 1905 days
Results posted on
2024-12-11
Participant Flow
Participants from Studies M16-008 (NCT02684370), M16-010 (NCT02694523), M15-995 (NCT02684357), M16-178 (NCT03255382), M16-009 (NCT02203851), M15-992 (NCT02672852), and M16-004 (NCT03000075) entered this open-label extension (OLE) study from 232 sites across 17 countries (Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Japan, Mexico, Poland, Portugal, Republic of Korea, Spain, Sweden, Taiwan, and US).
Participant milestones
| Measure |
Risankizumab 150 mg
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
2170
|
|
Overall Study
COMPLETED
|
1601
|
|
Overall Study
NOT COMPLETED
|
569
|
Reasons for withdrawal
| Measure |
Risankizumab 150 mg
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
142
|
|
Overall Study
Withdrawal by Subject
|
155
|
|
Overall Study
Lost to Follow-up
|
144
|
|
Overall Study
COVID-19 Infection
|
2
|
|
Overall Study
COVID-19 Logistical Restrictions
|
9
|
|
Overall Study
Other, Not Specified
|
117
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
Baseline characteristics by cohort
| Measure |
Risankizumab 150 mg
n=2170 Participants
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks
|
|---|---|
|
Age, Customized
< 40 years
|
658 Participants
n=5 Participants
|
|
Age, Customized
40 - < 65 years
|
1264 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
634 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1536 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
257 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1913 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
466 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1622 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow-up time of 1905 daysAn adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Outcome measures
| Measure |
Risankizumab 150 mg
n=2170 Participants
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks
|
|---|---|
|
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Serious Adverse Events
|
435 Participants
|
|
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Non-serious Adverse Events
|
1215 Participants
|
Adverse Events
Risankizumab 150 mg
Serious events: 435 serious events
Other events: 1215 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Risankizumab 150 mg
n=2170 participants at risk
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.14%
3/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.60%
13/2170 • Number of events 13 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ARRHYTHMIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.41%
9/2170 • Number of events 9 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Cardiac disorders
BIFASCICULAR BLOCK
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
BRADYCARDIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIAC ARREST
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.23%
5/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIAC VENTRICULAR THROMBOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.41%
9/2170 • Number of events 9 • Median follow-up time of 1905 days
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
DRESSLER'S SYNDROME
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.41%
9/2170 • Number of events 9 • Median follow-up time of 1905 days
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
PERICARDITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
PRINZMETAL ANGINA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
SINUS NODE DYSFUNCTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Congenital, familial and genetic disorders
CONGENITAL CYSTIC KIDNEY DISEASE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Congenital, familial and genetic disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Ear and labyrinth disorders
SUDDEN HEARING LOSS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Ear and labyrinth disorders
VERTIGO
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Endocrine disorders
GOITRE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Endocrine disorders
GRAVES' DISEASE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Endocrine disorders
THYROTOXIC CRISIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Eye disorders
BLINDNESS UNILATERAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Eye disorders
CATARACT
|
0.14%
3/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Eye disorders
EPIRETINAL MEMBRANE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Eye disorders
MACULAR HOLE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
ABDOMINAL INCARCERATED HERNIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
ASCITES
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
GASTRITIS
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
INCARCERATED UMBILICAL HERNIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.05%
1/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
RECTAL STENOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
RETROPERITONEAL MASS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
TOOTH DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Gastrointestinal disorders
VOMITING
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
DEATH
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
OEDEMA PERIPHERAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
PAIN
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
SUDDEN DEATH
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
SURGICAL FAILURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
General disorders
VASCULAR STENT STENOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
ALCOHOLIC LIVER DISEASE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.18%
4/2170 • Number of events 5 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
CIRRHOSIS ALCOHOLIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
GALLBLADDER POLYP
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Hepatobiliary disorders
HEPATITIS ALCOHOLIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
ABSCESS JAW
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
ABSCESS LIMB
|
0.09%
2/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Infections and infestations
APPENDICITIS
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Infections and infestations
BRONCHIOLITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
COVID-19
|
0.60%
13/2170 • Number of events 14 • Median follow-up time of 1905 days
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.32%
7/2170 • Number of events 7 • Median follow-up time of 1905 days
|
|
Infections and infestations
CELLULITIS
|
0.23%
5/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Infections and infestations
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
DIVERTICULITIS
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Infections and infestations
EPIDIDYMITIS
|
0.05%
1/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Infections and infestations
ERYSIPELAS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
FALLOPIAN TUBE ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
FOURNIER'S GANGRENE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
GAS GANGRENE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
GASTROENTERITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
HERPES ZOSTER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Infections and infestations
INFECTIVE GLOSSITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
LARGE INTESTINE INFECTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
MEDIASTINAL ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
MENINGITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
NEUROSYPHILIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
ORCHITIS
|
0.09%
2/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Infections and infestations
OSTEOMYELITIS
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Infections and infestations
PERICORONITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PERITONITIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PNEUMONIA
|
0.32%
7/2170 • Number of events 7 • Median follow-up time of 1905 days
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PSOAS ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
PYELONEPHRITIS
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.09%
2/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Infections and infestations
RENAL ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
SCROTAL ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
SEPSIS
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Infections and infestations
SEPTIC SHOCK
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
TONSILLITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
UROSEPSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Infections and infestations
VESTIBULAR NEURONITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
ACETABULUM FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
CARTILAGE INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
COLON INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
CRANIOFACIAL FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
FALL
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LIMB TRAUMATIC AMPUTATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
TENDON DISLOCATION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Metabolism and nutrition disorders
OBESITY
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.28%
6/2170 • Number of events 6 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
LOOSE BODY IN JOINT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.78%
17/2170 • Number of events 20 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SPINAL LIGAMENT OSSIFICATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SPINAL STENOSIS
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
TENDINOUS CONTRACTURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BORDERLINE MUCINOUS TUMOUR OF OVARY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM MALIGNANT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER RECURRENT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER STAGE II
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHROMOPHOBE RENAL CELL CARCINOMA
|
0.05%
1/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CLEAR CELL RENAL CELL CARCINOMA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER METASTATIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER STAGE 0
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOCARCINOMA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL ADENOMA
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL ADENOCARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER STAGE II
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GERM CELL CANCER METASTATIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF LIVER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE LOBULAR BREAST CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL CANCER STAGE II
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL SQUAMOUS CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOSARCOMA METASTATIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA IN SITU
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA STAGE IV
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PENILE SQUAMOUS CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PLASMA CELL MYELOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER STAGE IV
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SARCOMA UTERUS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SCHWANNOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE TONGUE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUPERFICIAL SPREADING MELANOMA STAGE I
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRIPLE NEGATIVE BREAST CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE MYOMA EXPULSION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
BELL'S PALSY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.23%
5/2170 • Number of events 5 • Median follow-up time of 1905 days
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Nervous system disorders
DEMENTIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
DIZZINESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
EPILEPSY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
HEADACHE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
HEMIPARESIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.23%
5/2170 • Number of events 5 • Median follow-up time of 1905 days
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
NEURALGIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
PARAESTHESIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
PRESYNCOPE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
PROGRESSIVE SUPRANUCLEAR PALSY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
SEIZURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
SYNCOPE
|
0.32%
7/2170 • Number of events 7 • Median follow-up time of 1905 days
|
|
Nervous system disorders
THALAMIC INFARCTION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Nervous system disorders
TOXIC ENCEPHALOPATHY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.23%
5/2170 • Number of events 5 • Median follow-up time of 1905 days
|
|
Nervous system disorders
VERTEBROBASILAR INSUFFICIENCY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Pregnancy, puerperium and perinatal conditions
ECLAMPSIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
ANOREXIA NERVOSA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
ANXIETY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
CATATONIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
DEPRESSION
|
0.14%
3/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
POST-TRAUMATIC AMNESTIC DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
POST-TRAUMATIC STRESS DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
SOMATIC SYMPTOM DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
CYSTITIS INTERSTITIAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.37%
8/2170 • Number of events 9 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
PELVI-URETERIC OBSTRUCTION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
PYELOCALIECTASIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
RENAL ARTERY STENOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
RENAL COLIC
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Renal and urinary disorders
RENAL CYST
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
BALANOPOSTHITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
BREAST ENLARGEMENT
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
ENDOMETRIAL DISORDER
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.05%
1/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.28%
6/2170 • Number of events 7 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Skin and subcutaneous tissue disorders
LICHEN PLANUS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Skin and subcutaneous tissue disorders
PRECANCEROUS SKIN LESION
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Social circumstances
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Surgical and medical procedures
ABDOMINOPLASTY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.18%
4/2170 • Number of events 4 • Median follow-up time of 1905 days
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.14%
3/2170 • Number of events 3 • Median follow-up time of 1905 days
|
|
Vascular disorders
AORTIC STENOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Vascular disorders
EMBOLISM ARTERIAL
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
HYPERTENSION
|
0.09%
2/2170 • Number of events 2 • Median follow-up time of 1905 days
|
|
Vascular disorders
HYPERTENSIVE URGENCY
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
VARICOSE VEIN
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
|
Vascular disorders
VASCULAR STENOSIS
|
0.05%
1/2170 • Number of events 1 • Median follow-up time of 1905 days
|
Other adverse events
| Measure |
Risankizumab 150 mg
n=2170 participants at risk
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks
|
|---|---|
|
Infections and infestations
COVID-19
|
16.6%
360/2170 • Number of events 384 • Median follow-up time of 1905 days
|
|
Infections and infestations
NASOPHARYNGITIS
|
22.1%
480/2170 • Number of events 833 • Median follow-up time of 1905 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.4%
312/2170 • Number of events 467 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
217/2170 • Number of events 267 • Median follow-up time of 1905 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.7%
124/2170 • Number of events 142 • Median follow-up time of 1905 days
|
|
Nervous system disorders
HEADACHE
|
6.2%
134/2170 • Number of events 211 • Median follow-up time of 1905 days
|
|
Vascular disorders
HYPERTENSION
|
10.5%
227/2170 • Number of events 245 • Median follow-up time of 1905 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place