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    Clinical Trial Results:
    A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis

    Summary
    EudraCT number
    		 2016-003046-87
    Trial protocol
    		 AT   SE   BE   DE   FI   CZ   PL   PT   ES   FR  
    Global end of trial date
    30 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2024
    First version publication date
    06 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-997
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03047395
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of Study M15-997 is to investigate long-term safety and tolerability of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 61
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Canada: 432
    Country: Number of subjects enrolled
    Czechia: 38
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 256
    Country: Number of subjects enrolled
    Japan: 217
    Country: Number of subjects enrolled
    Korea, Republic of: 94
    Country: Number of subjects enrolled
    Mexico: 39
    Country: Number of subjects enrolled
    Poland: 86
    Country: Number of subjects enrolled
    Portugal: 19
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Taiwan: 51
    Country: Number of subjects enrolled
    United States: 815
    Worldwide total number of subjects
    2170
    EEA total number of subjects
    461
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1922
    From 65 to 84 years
    247
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants from Studies M16-008, M16-010, M15-995, M16-178, M16-009, M15-992, and M16-004 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, US).

    Pre-assignment
    Screening details
    		 Participants were eligible for study enrollment if he/she met all inclusion criteria and none of the exclusion criteria at the Baseline visit.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Risankizumab 150 mg
    Arm description
    		 Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi, BI 655066
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

    Number of subjects in period 1
    		Risankizumab 150 mg
    Started
    2170
    Completed
    1601
    Not completed
    569
         Consent withdrawn by subject
    155
         Other, not specified
    117
         Adverse event
    142
         COVID-19 logistical restrictions
    9
         Lost to follow-up
    144
         COVID-19 infection
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Risankizumab 150 mg
    Reporting group description
    		 Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

    Reporting group values
    		 Risankizumab 150 mg Total
    Number of subjects
    		 2170 2170
    Age categorical
    Units: Subjects
        < 40 years
    		 658 658
        40 - < 65 years
    		 1264 1264
        >= 65 years
    		 248 248
    Gender categorical
    Units: Subjects
        Female
    		 634 634
        Male
    		 1536 1536
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 257 257
        Not Hispanic or Latino
    		 1913 1913
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 15 15
        Asian
    		 466 466
        Native Hawaiian or Other Pacific Islander
    		 9 9
        Black or African American
    		 50 50
        White
    		 1622 1622
        More than one race
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Risankizumab 150 mg
    Reporting group description
    		 Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

    Primary: Number of Participants With Serious Adverse Events or Non-Serious Adverse Events

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    End point title
    		 Number of Participants With Serious Adverse Events or Non-Serious Adverse Events [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Median follow-up time of 1905 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 Risankizumab 150 mg
    Number of subjects analysed
    2170
    Units: participants
        Serious Adverse Events
    435
        Non-serious Adverse Events
    1215
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Median follow-up time of 1905 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Risankizumab 150mg
    Reporting group description
    		 Risankizumab 150 mg administered by subcutaneous injection every 12 weeks

    Serious adverse events
    		 Risankizumab 150mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    435 / 2170 (20.05%)
         number of deaths (all causes)
    28
         number of deaths resulting from adverse events
    28
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLORECTAL ADENOCARCINOMA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ANAL CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    BASAL CELL CARCINOMA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    BILE DUCT CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BLADDER CANCER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    BLADDER TRANSITIONAL CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BORDERLINE MUCINOUS TUMOUR OF OVARY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BRAIN NEOPLASM MALIGNANT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLON CANCER STAGE 0
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    COLON CANCER METASTATIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    CLEAR CELL RENAL CELL CARCINOMA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    CHRONIC LYMPHOCYTIC LEUKAEMIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHROMOPHOBE RENAL CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    BREAST CANCER STAGE II
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BREAST CANCER RECURRENT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    BREAST CANCER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    INVASIVE LOBULAR BREAST CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LARYNGEAL CANCER STAGE II
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LARYNGEAL SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LIPOSARCOMA METASTATIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    LUNG ADENOCARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LUNG CANCER METASTATIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    LUNG NEOPLASM MALIGNANT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLORECTAL ADENOMA
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    COLORECTAL CANCER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    ENDOMETRIAL ADENOCARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENDOMETRIAL CANCER STAGE II
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTRIC CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    GERM CELL CANCER METASTATIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GLIOBLASTOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMANGIOMA OF LIVER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    HEPATIC CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INVASIVE BREAST CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    INVASIVE DUCTAL BREAST CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MALIGNANT MELANOMA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SARCOMA UTERUS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MENINGIOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    METASTATIC SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PANCREATIC CARCINOMA
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    PANCREATIC CARCINOMA STAGE IV
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PAPILLARY THYROID CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PENILE SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PLASMA CELL MYELOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    PROSTATE CANCER METASTATIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROSTATE CANCER STAGE IV
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTAL ADENOCARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTAL CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MALIGNANT MELANOMA IN SITU
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    UTERINE CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TRANSITIONAL CELL CARCINOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUPERFICIAL SPREADING MELANOMA STAGE I
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SQUAMOUS CELL CARCINOMA OF THE TONGUE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SQUAMOUS CELL CARCINOMA OF SKIN
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SCHWANNOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UTERINE LEIOMYOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UTERINE MYOMA EXPULSION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TRIPLE NEGATIVE BREAST CANCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    HYPERTENSIVE URGENCY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    EMBOLISM ARTERIAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    AORTIC ANEURYSM
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    AORTIC STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ARTERIOSCLEROSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    VARICOSE VEIN
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PELVIC VENOUS THROMBOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VASCULAR STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    ABDOMINOPLASTY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABORTION INDUCED
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    ECLAMPSIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABORTION SPONTANEOUS
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    SURGICAL FAILURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEATH
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    MULTIPLE ORGAN DYSFUNCTION SYNDROME
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PAIN
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUDDEN CARDIAC DEATH
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    SUDDEN DEATH
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    VASCULAR STENT STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    BALANOPOSTHITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BREAST ENLARGEMENT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CYSTOCELE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENDOMETRIAL DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENDOMETRIOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEAVY MENSTRUAL BLEEDING
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROSTATITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PNEUMOTHORAX
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    ASTHMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    COUGH
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NASAL SEPTUM DEVIATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    RESPIRATORY DISTRESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    COMPLETED SUICIDE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CATATONIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BIPOLAR DISORDER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ANXIETY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ANOREXIA NERVOSA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ALCOHOL WITHDRAWAL SYNDROME
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ALCOHOL ABUSE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    CONFUSIONAL STATE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEPRESSED MOOD
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEPRESSION
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    POST-TRAUMATIC AMNESTIC DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST-TRAUMATIC STRESS DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SCHIZOPHRENIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SOMATIC SYMPTOM DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    AUTOIMMUNE HEPATITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHOLECYSTITIS
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    CHOLECYSTITIS ACUTE
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    CIRRHOSIS ALCOHOLIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GALLBLADDER POLYP
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEPATIC CIRRHOSIS
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    HEPATITIS ALCOHOLIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ALCOHOLIC LIVER DISEASE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    CARTILAGE INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACETABULUM FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ALCOHOL POISONING
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLON INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LIMB INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CONTUSION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CRANIOCEREBRAL INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CRANIOFACIAL FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FALL
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    FEMUR FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    FIBULA FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    HAND FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTENTIONAL OVERDOSE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    JOINT DISLOCATION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LIGAMENT INJURY
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LIGAMENT RUPTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    CONCUSSION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LIMB TRAUMATIC AMPUTATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LOWER LIMB FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LUMBAR VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MENISCUS INJURY
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    MULTIPLE INJURIES
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NAIL INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PATELLA FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL COMPLICATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL HAEMATOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL SWELLING
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RADIUS FRACTURE
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    SKIN ABRASION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TENDON DISLOCATION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    TENDON INJURY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ULNA FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    TOXICITY TO VARIOUS AGENTS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    THERMAL BURN
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TENDON RUPTURE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    ATRIAL SEPTAL DEFECT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CONGENITAL CYSTIC KIDNEY DISEASE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERTROPHIC CARDIOMYOPATHY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    AORTIC VALVE INCOMPETENCE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    13 / 2170 (0.60%)
         occurrences causally related to treatment / all
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    ANGINA PECTORIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ANGINA UNSTABLE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACUTE CORONARY SYNDROME
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ARRHYTHMIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CORONARY ARTERY OCCLUSION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    9 / 2170 (0.41%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIAL TACHYCARDIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIOVENTRICULAR BLOCK FIRST DEGREE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ATRIOVENTRICULAR BLOCK SECOND DEGREE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    BIFASCICULAR BLOCK
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BRADYCARDIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    5 / 2170 (0.23%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    1 / 1
    CARDIAC VENTRICULAR THROMBOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CARDIOMYOPATHY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CARDIOVASCULAR DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    9 / 2170 (0.41%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    ARTERIOSCLEROSIS CORONARY ARTERY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DRESSLER'S SYNDROME
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERICARDITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PRINZMETAL ANGINA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SINUS NODE DYSFUNCTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VENTRICULAR FIBRILLATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    9 / 2170 (0.41%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    BELL'S PALSY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    CEREBRAL HAEMATOMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CEREBRAL HAEMORRHAGE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    5 / 2170 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    5 / 2170 (0.23%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    HYPOAESTHESIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEMIPARESIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HEADACHE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMORRHAGIC STROKE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    EPILEPSY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DIZZINESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEMENTIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    METABOLIC ENCEPHALOPATHY
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SEIZURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RUPTURED CEREBRAL ANEURYSM
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PROGRESSIVE SUPRANUCLEAR PALSY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PARTIAL SEIZURES
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PARAESTHESIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NEURALGIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MULTIPLE SCLEROSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SENSORY DISTURBANCE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYNCOPE
         subjects affected / exposed
    7 / 2170 (0.32%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    THALAMIC INFARCTION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    TOXIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    5 / 2170 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    VERTEBROBASILAR INSUFFICIENCY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    STATUS EPILEPTICUS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMOLYSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PANCYTOPENIA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    SUDDEN HEARING LOSS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VERTIGO
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VERTIGO POSITIONAL
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    BLINDNESS UNILATERAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CATARACT
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    EPIRETINAL MEMBRANE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    MACULAR HOLE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    GASTRIC ULCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABDOMINAL INCARCERATED HERNIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ASCITES
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHRONIC GASTRITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLITIS ISCHAEMIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DUODENAL ULCER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DYSPEPSIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTRIC ULCER HAEMORRHAGE
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    GASTRITIS EROSIVE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    HAEMATEMESIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMATOCHEZIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INCARCERATED INGUINAL HERNIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INCARCERATED UMBILICAL HERNIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL ISCHAEMIA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LARGE INTESTINE PERFORATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LARGE INTESTINE POLYP
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OESOPHAGEAL STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    OESOPHAGITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTRITIS
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    PANCREATITIS ACUTE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTAL STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RETROPERITONEAL MASS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    TOOTH DISORDER
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VOMITING
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    ANGIOEDEMA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ECZEMA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LICHEN PLANUS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PRECANCEROUS SKIN LESION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    STEVENS-JOHNSON SYNDROME
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    PYELOCALIECTASIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL ARTERY STENOSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL COLIC
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    CALCULUS URINARY
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    CYSTITIS INTERSTITIAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYDRONEPHROSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NEPHROLITHIASIS
         subjects affected / exposed
    8 / 2170 (0.37%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    PELVI-URETERIC OBSTRUCTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL CYST
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    GOITRE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    GRAVES' DISEASE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    THYROTOXIC CRISIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERTHYROIDISM
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ARTHRALGIA
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OSTEONECROSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    17 / 2170 (0.78%)
         occurrences causally related to treatment / all
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    LUMBAR SPINAL STENOSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LOOSE BODY IN JOINT
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    FOOT DEFORMITY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CERVICAL SPINAL STENOSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PSORIATIC ARTHROPATHY
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TENDINOUS CONTRACTURE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYSTEMIC LUPUS ERYTHEMATOSUS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYNOVITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYNOVIAL CYST
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SPONDYLOLISTHESIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SPINAL STENOSIS
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    SPINAL LIGAMENT OSSIFICATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    TENOSYNOVITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    BRONCHIOLITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    ABSCESS JAW
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABSCESS LIMB
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    ARTHRITIS BACTERIAL
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    BURSITIS INFECTIVE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    INTERVERTEBRAL DISCITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHRONIC TONSILLITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    13 / 2170 (0.60%)
         occurrences causally related to treatment / all
    3 / 14
         deaths causally related to treatment / all
    1 / 5
    COVID-19 PNEUMONIA
         subjects affected / exposed
    7 / 2170 (0.32%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 2
    DIVERTICULITIS
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    EPIDIDYMITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    ERYSIPELAS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FALLOPIAN TUBE ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FOURNIER'S GANGRENE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GAS GANGRENE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HERPES ZOSTER
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    INFECTIVE GLOSSITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CELLULITIS
         subjects affected / exposed
    5 / 2170 (0.23%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    LARGE INTESTINE INFECTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PSOAS ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MENINGITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NEUROSYPHILIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    ORCHITIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    OSTEOMYELITIS
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    PERICORONITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERIRECTAL ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERITONITIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PERITONSILLAR ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    7 / 2170 (0.32%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL INFECTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POSTOPERATIVE ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PSEUDOMONAL SEPSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MEDIASTINAL ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    RENAL ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SCROTAL ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    SEPSIS
         subjects affected / exposed
    6 / 2170 (0.28%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VESTIBULAR NEURONITIS
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PYELONEPHRITIS ACUTE
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DIABETES MELLITUS
         subjects affected / exposed
    3 / 2170 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    DIABETIC KETOACIDOSIS
         subjects affected / exposed
    2 / 2170 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    ELECTROLYTE IMBALANCE
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 2170 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OBESITY
         subjects affected / exposed
    4 / 2170 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Risankizumab 150mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1215 / 2170 (55.99%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    227 / 2170 (10.46%)
         occurrences all number
    245
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    134 / 2170 (6.18%)
         occurrences all number
    211
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    124 / 2170 (5.71%)
         occurrences all number
    142
    ARTHRALGIA
         subjects affected / exposed
    217 / 2170 (10.00%)
         occurrences all number
    267
    Infections and infestations
    COVID-19
         subjects affected / exposed
    360 / 2170 (16.59%)
         occurrences all number
    384
    NASOPHARYNGITIS
         subjects affected / exposed
    480 / 2170 (22.12%)
         occurrences all number
    833
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    312 / 2170 (14.38%)
         occurrences all number
    467

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2016
    The purpose of this amendment is to: ● Specify primary objective of the study is to investigate long term safety and tolerability of risankizumab in subjects with psoriasis. ● Specify secondary objective of the study is to investigate long term efficacy of risankizumab in subjects with psoriasis. ● Add Inclusion Criterion 2 from Section 1.1, Synopsis, to Section 5.2.1, Inclusion Criteria. ● Clarify Section 5.2.4, Contraception Recommendations and Pregnancy Testing, contraception language regarding methotrexate (MTX). ● Add definition of the PASI50 endpoint to Section 5.3.3.2, Additional Variables. ● Add the 25th and 75th percentiles to Section 8.1.4, Statistical Analysis of Efficacy. ● Add the 95% Confidence Intervals to Section 8.1.4, Statistical Analysis of Efficacy. ● Add a detailed description of the pharmacokinetic analysis. ● Add details on Use of Information (Section 12.0, Use of Information). ● Add details on Data Quality Assurance (Section 11.0, Data Quality Assurance).
    06 Jun 2017
    The purpose of this amendment is to: ● Add Study M16-178 as additional preceding study that could enroll subjects in Study M15-997. ● Increase expected number of subjects enrolled to 2000. ● Add the possibility to have qualified and delegated site staff members to perform the efficacy assessments. ● Add "arm" as additional possible injection site. ● Update the relationship to study drug definitions. ● Add information on Interim Database Lock in Q4 2017. ● Correct typographical and grammatical errors throughout the document.
    10 Jan 2018
    The purpose of this amendment is to: ● Add Study 1311.13 as additional preceding study that could enroll subjects in Study M15-997. • Update the exception for prohibited topical treatments for psoriasis or any other skin condition.
    21 Jun 2018
    The purpose of this amendment is to: ● Extend the period between the last administered dose of risankizumab and the End of Observation Visit from 16 to 20 weeks. ● Update the number of subjects to be enrolled to approximately 2200. ● Revise inclusion and exclusion criteria to require that women of childbearing potential use contraception throughout the study, including 20 weeks after the last dose of study drug, and exclude subjects who are pregnant, breastfeeding or considering becoming pregnant throughout the study, including 20 weeks after the last dose of study drug. ● Add the establishment of an independent external Anaphylaxis Adjudication Committee (AAC). ● Add request to draw additional blood samples in case of a suspected systemic post-dose hypersensitivity reaction and conduct additional blood tests in case of a systemic hypersensitivity reaction. ● Update the treatment-emergent AE definition to include events until 20 weeks (140 days) after the last risankizumab injection. ● Decrease the pharmacokinetic (PK) and anti-drug antibody (ADA) sample collection. ● Correct typographical and grammatical errors and make some small clarifying changes throughout the document.
    24 Sep 2019
    The purpose of this amendment is to: ● Update the Sponsor/Emergency contact/Primary Therapeutic Area Medical Director ● Extend the study duration from 156 weeks to 252 weeks with study visits every 24 weeks after Week 156. ● Allow self-administration of risankizumab at home at Weeks 168, 192, 216 and 240 and add corresponding requirements for this. ● Update the Introduction and the Benefits and Risks section of the protocol to match the latest Investigator Brochure. ● Remove the need to consult with the AbbVie TAMD for use of lower potency topical steroids and define the limited period of time for use being approximately 6 weeks. ● Add clearer guidance on when study drug administration may resume after being postponed for a serious infection. ● Remove drug storage temperature excursion requirements. ● Remove the necessity to retain empty IP boxes and sharps containers at site until the AbbVie monitor is on site to confirm the medication. ● Update the definitions of analysis populations. ● Remove short-term efficacy summary. ● Correct typographical and grammatical errors and make some small clarifying changes throughout the document.
    26 Nov 2019
    The purpose of this amendment is to: • Remove the sentence "In the event that a suspected anaphylactic reaction occurs while the subject is not on site at the study clinic, the treating facility should be advised to perform serum tryptase and histamine to help better understand and characterize the diagnosis." from the section Monitoring for Hypersensitivity Reaction.
    17 Nov 2020
    The purpose of this amendment is to: Incorporate necessary protocol modifications due to the COVID-19 pandemic as follows: ● Section 1.3 – added COVID-19 Specific Abbreviations ● Section 3.2 – included information on the re-evaluation of the benefit and risk to subjects participating in the study. ● Section 5.1 – added that study visits may be impacted due to the COVID-19 pandemic. ● Section 5.3.1.1 – updated to include details on how to perform specific activities/procedures that may be impacted by changes in global/local regulations due to the pandemic ● Section 5.4.1 – included guidance on interruption or discontinuation of study drug due to COVID-19 infection ● Section 5.5.4 – included instructions on possible Direct-to patient study drug shipment ● Section 6.1.5 – added information on reporting requirements in the eCRF in the event of COVID-19 related missed/virtual visits, study drug interruptions or discontinuation, or adverse events ● Section 7.0 – clarified that protocol deviations may include modifications due to COVID-19 ● Section 10.2 – noted that supplemental study case report form should be completed in the event of COVID-19 related missed/virtual visits, study drug discontinuations, or adverse events and that remote monitoring may be employed as needed. ● State that monitoring by the independent Data Monitoring Committee will no longer be in effect for this open-label study. ● Clarify which cardiovascular adverse events will be formally adjudicated. ● Clarify the discontinuation criteria. ● Clarify that following discontinuation of study drug subjects can be treated in accordance with the Investigator's best clinical judgement. ● Update the Sponsor/Emergency contact/Primary Therapeutic Area Medical Director.
    18 Oct 2021
    The purpose of this amendment is to: ● Throughout the protocol, remove the requirement for the physical exam, clinical laboratory samples and efficacy assessments PASI, sPGA, NAPSI, PPASI, PSSI, and the DLQI at the End of Observation (EOO) visit and change the EOO visit from an in-person visit to a phone visit. ● Change the End of Observation visit requirement to perform an ECG, TB testing and additional clinical laboratory testing to the EOT visit in Appendix C ("Study Activities Flow Chart"). ● Clarify the analysis of the immunogenicity samples in Section 5.3.2.4 ("Measurement Methods"). ● Add INR test to be performed if ALT or AST > 3 x ULN to Table 1 Clinical Laboratory Test in Section 5.3.1.1 ("Study Procedures"). ●Update the definition of hepatic injury to include marked peak aminotransferase elevations ≥ 8-fold ULN, instead of ≥ 10-fold ULN in Section 6.1.1.3 ("Adverse Events of Special Interests"). ● Clarify in Section 6.1.1.3 Adverse Events of Special Interests, that the supplemental hepatic eCRFs have to be completed for any hepatic related AE leading to discontinuation or interruption of study drug or any hepatic related SAE, not meeting the hepatic injury definition. ● Add language to address potential use of SARS-CoV-2 vaccines to Section 5.2.3 ("Prior and Concomitant Therapy") and Section 6.1.5 ("Adverse Event Reporting"). ● Update the Sponsor/Emergency contact/Primary Therapeutic Area Medical Director and Alternate Contact for Protocol Deviations in Section 1.0 ("Title Page"), Section 6.1.5 ("Adverse Event Reporting") and Section 7.0 ("Protocol Deviations").

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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