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    Clinical Trial Results:
    Randomized phase III study of a treatment driven by early PET response compared to a treatment not monitored by early PET in patients with Ann Arbor Stage III-IV or high risk IIB Hodgkin lymphoma

    Summary
    EudraCT number
    		 2010-022844-19
    Trial protocol
    		 FR   BE  
    Global end of trial date
    30 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2023
    First version publication date
    07 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AHL2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01358747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Hospitalier Universitaire de Dijon
    Sponsor organisation address
    1 boulevard Jeanne d'Arc, DIJON CEDEX, France, 21079
    Public contact
    Project Management, LYSARC, contact@lysarc.org
    Scientific contact
    Project Management, Pr Olivier Casasnovas, olivier.casasnovas@chu-dijon.fr
    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
    19 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the non inferiority in term of progression free survival (PFS) of a therapeutic strategy driven by PET with a ABVD conventional dose chemotherapy for patients reaching a negative PET after 2 cycles of BEACOPPesc, compared to a treatment not monitored by early PET delivering 6 cycles of BEACOPPesc.
    Protection of trial subjects
    DSMC periodically reviewed the safety and efficacy data from the trial prepared by the independent statistician. All data presented at the meeting were confidential. Following each meeting the DMSC prepared a report and may recommended changes in the trial conduct.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2011
    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
    Belgium: 765
    Country: Number of subjects enrolled
    France: 58
    Worldwide total number of subjects
    823
    EEA total number of subjects
    823
    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)
    16
    Adults (18-64 years)
    807
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 88 study centers in France and Belgium. Date first subject first visit: 19 May 2011 Date last subject completed: 29 April 2019

    Pre-assignment
    Screening details
    		 Male or female adult (aged 16 to 60 years old) subjects with histologically proven HL not previously treated, with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2, and life expectancy ≥ 90 days were eligible for participation in the study

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard Arm
    Arm description
    		 Patients were treated by a BEACOPPesc regimen every 3 weeks for 4 cycles. A PET was performed after 2 cycles of chemotherapy (PET2) with no decisional value, and after 4 cycles with decisional value. In case of PET4 negative result, patient received 2 additional cycles of BEACOPPesc delivered every 3 weeks In case of PET4 positive result, patient received a salvage therapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/m2 at Day 8

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg/m2 at days 1, 2and 3

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    35 mg/ m2 on day 1

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250 mg/m2 on day 1

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.4 mg/m2 on day 1

    Investigational medicinal product name
    Procarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 100 mg/m2 Administration: Daily from Day 1 of each cycle to day 7

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 40mg/m2 Administration: Daily from Day 1 of each cycle to day 8 and day 9 to day 14

    Investigational medicinal product name
    Lenograstim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5 microgr/kg/day start on day 9

    Arm title
    		 Experiimental arm
    Arm description
    		 Patients were treated by a BEACOPPesc regimen every 3 weeks for 2 cycles followed by a PET scan (PET2). After PET2 central review: - In case of positive PET2, the treatment was completed by 2 additional cycles of BEACOPPesc (induction treatment = 4 x BEACOPPesc) - In case of negative PET2, the treatment was completed by 2 cycles of ABVD delivered every 4 weeks (induction treatment = 2 x BEACOPPesc + 2 x ABVD). After PET4 central review: - In case of positive PET4, a salvage therapy was decided by the investigator - In case of negative PET4 : - if PET2 was negative, treatment was completed by 2 cycles of ABVD (induction treatment = 2 x BEACOPPesc + 4 x ABVD). - if PET2 was positive, treatment was completed by 2 cycles of BEACOPPesc (induction treatment = 4 x BEACOPPesc)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/m2 at Day 8

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg/m2 at days 1, 2and 3

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    35 mg/ m2 on day 1

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250 mg/m2 on day 1

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.4 mg/m2 on day 1

    Investigational medicinal product name
    Procarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 100 mg/m2 Administration: Daily from Day 1 of each cycle to day 7

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 40mg/m2 Administration: Daily from Day 1 of each cycle to day 8 and day 9 to day 14

    Investigational medicinal product name
    Lenograstim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5 microgr/kg/day start on day 9

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/ m2 on day 1 and day 15

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/m2 on day 1 and day 15

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/m2 on day 1 and day 15

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m2 on day 1 and day 15

    Number of subjects in period 1
    		Standard Arm Experiimental arm
    Started
    413
    410
    Completed
    342
    359
    Not completed
    71
    51
         Consent withdrawn by subject
    4
    3
         Physician decision
    2
    3
         death
    4
    2
         Adverse event, non-fatal
    28
    4
         other
    4
    3
         Lack of efficacy
    26
    19
         Protocol deviation
    3
    17

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 823 823
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
        Subjects
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 32.9 (16 to 60) -
    Gender categorical
    Units: Subjects
        Female
    		 307 307
        Male
    		 516 516
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set contains all patients who were formally randomized regardless whether they have received treatment or not (following an intent-to-treat principle). Patients are analyzed according to the treatment arm they were randomized to receive. The ITT set is used for the efficacy analysis.

    Subject analysis sets values
    		 ITT
    Number of subjects
    823
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
        Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    32.9 (16 to 60)
    Gender categorical
    Units: Subjects
        Female
    307
        Male
    516

    End points

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    End points reporting groups
    Reporting group title
    Standard Arm
    Reporting group description
    		 Patients were treated by a BEACOPPesc regimen every 3 weeks for 4 cycles. A PET was performed after 2 cycles of chemotherapy (PET2) with no decisional value, and after 4 cycles with decisional value. In case of PET4 negative result, patient received 2 additional cycles of BEACOPPesc delivered every 3 weeks In case of PET4 positive result, patient received a salvage therapy

    Reporting group title
    Experiimental arm
    Reporting group description
    		 Patients were treated by a BEACOPPesc regimen every 3 weeks for 2 cycles followed by a PET scan (PET2). After PET2 central review: - In case of positive PET2, the treatment was completed by 2 additional cycles of BEACOPPesc (induction treatment = 4 x BEACOPPesc) - In case of negative PET2, the treatment was completed by 2 cycles of ABVD delivered every 4 weeks (induction treatment = 2 x BEACOPPesc + 2 x ABVD). After PET4 central review: - In case of positive PET4, a salvage therapy was decided by the investigator - In case of negative PET4 : - if PET2 was negative, treatment was completed by 2 cycles of ABVD (induction treatment = 2 x BEACOPPesc + 4 x ABVD). - if PET2 was positive, treatment was completed by 2 cycles of BEACOPPesc (induction treatment = 4 x BEACOPPesc)

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set contains all patients who were formally randomized regardless whether they have received treatment or not (following an intent-to-treat principle). Patients are analyzed according to the treatment arm they were randomized to receive. The ITT set is used for the efficacy analysis.

    Primary: PFS

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    End point title
    		 PFS
    End point description
    The primary endpoint was progression-free survival. PFS was measured from the date of randomization to the date of first documented progression of the lymphoma in non-responding patients, relapse for CR patients or death from any cause without progression, whichever occurs first
    End point type
    Primary
    End point timeframe
    5-year progression-free survival
    End point values
    		 Standard Arm Experiimental arm
    Number of subjects analysed
    413
    410
    Units: percent
        arithmetic mean (confidence interval 95%)
    87.5 (83.9 to 90.4)
    86.7 (83.0 to 89.7)
    Attachments
    		 Untitled (Filename: PFS.png)
    Statistical analysis title
    		 Comparison according to treatment arm
    Statistical analysis description
    Based on a Cox model, the Hazard Ratio (HR) of patients in experimental treatment are compared to patients in standard arm.
    Comparison groups
    Standard Arm v Experiimental arm
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.64
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.071
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.738
         upper limit
    		 1.554
    Notes
    [1] - The Com-Nougue non-inferiority test for PFS gave a similar conclusion in the ITT population by rejecting the null hypothesis (p=0.0037).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any episode of any grade of toxicities, related to a Serious Adverse Event must be reported as “Serious Adverse Event” · Non-serious adverse events not to be reported. · The following events are not to be reported as SAE if require hospitalization le
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    BEACOPP only
    Reporting group description
    		 patients who received BEACOPP only and who performed cycle 1

    Reporting group title
    BEACOPP + ABVD
    Reporting group description
    		 -

    Serious adverse events
    		 BEACOPP only BEACOPP + ABVD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    160 / 458 (34.93%)
    97 / 361 (26.87%)
         number of deaths (all causes)
    19
    10
         number of deaths resulting from adverse events
    6
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
         subjects affected / exposed
    7 / 458 (1.53%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    8 / 8
    3 / 3
         deaths causally related to treatment / all
    2 / 3
    1 / 2
    Vascular disorders
    VASCULAR DISORDERS
         subjects affected / exposed
    11 / 458 (2.40%)
    9 / 361 (2.49%)
         occurrences causally related to treatment / all
    3 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
         subjects affected / exposed
    30 / 458 (6.55%)
    16 / 361 (4.43%)
         occurrences causally related to treatment / all
    13 / 37
    10 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    IMMUNE SYSTEM DISORDERS
         subjects affected / exposed
    4 / 458 (0.87%)
    5 / 361 (1.39%)
         occurrences causally related to treatment / all
    2 / 4
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    REPRODUCTIVE SYSTEM AND BREAST DISORDERS
         subjects affected / exposed
    2 / 458 (0.44%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
         subjects affected / exposed
    19 / 458 (4.15%)
    15 / 361 (4.16%)
         occurrences causally related to treatment / all
    14 / 21
    11 / 18
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
         subjects affected / exposed
    2 / 458 (0.44%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    CARDIAC DISORDERS
         subjects affected / exposed
    8 / 458 (1.75%)
    10 / 361 (2.77%)
         occurrences causally related to treatment / all
    3 / 8
    3 / 11
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Nervous system disorders
    NERVOUS SYSTEM DISORDERS
         subjects affected / exposed
    3 / 458 (0.66%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    BLOOD AND LYMPHATIC SYSTEM DISORDERS
         subjects affected / exposed
    29 / 458 (6.33%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    30 / 33
    13 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    EYE DISORDERS
         subjects affected / exposed
    0 / 458 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL DISORDERS
         subjects affected / exposed
    20 / 458 (4.37%)
    8 / 361 (2.22%)
         occurrences causally related to treatment / all
    21 / 26
    7 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
         subjects affected / exposed
    5 / 458 (1.09%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    SKIN AND SUBCUTANEOUS TISSUE DISORDERS
         subjects affected / exposed
    3 / 458 (0.66%)
    5 / 361 (1.39%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL AND URINARY DISORDERS
         subjects affected / exposed
    6 / 458 (1.31%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
         subjects affected / exposed
    7 / 458 (1.53%)
    4 / 361 (1.11%)
         occurrences causally related to treatment / all
    7 / 10
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    INFECTIONS AND INFESTATIONS
         subjects affected / exposed
    90 / 458 (19.65%)
    42 / 361 (11.63%)
         occurrences causally related to treatment / all
    91 / 121
    43 / 56
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Metabolism and nutrition disorders
    METABOLISM AND NUTRITION DISORDERS
         subjects affected / exposed
    2 / 458 (0.44%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BEACOPP only BEACOPP + ABVD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    458 / 458 (100.00%)
    361 / 361 (100.00%)
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    68 / 458 (14.85%)
    59 / 361 (16.34%)
         occurrences all number
    68
    59
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    354 / 458 (77.29%)
    275 / 361 (76.18%)
         occurrences all number
    354
    275
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    8 / 458 (1.75%)
    11 / 361 (3.05%)
         occurrences all number
    8
    11
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    146 / 458 (31.88%)
    104 / 361 (28.81%)
         occurrences all number
    146
    104
    Investigations
    Investigations
         subjects affected / exposed
    199 / 458 (43.45%)
    152 / 361 (42.11%)
         occurrences all number
    199
    152
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    40 / 458 (8.73%)
    28 / 361 (7.76%)
         occurrences all number
    40
    28
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    157 / 458 (34.28%)
    123 / 361 (34.07%)
         occurrences all number
    157
    123
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    458 / 458 (100.00%)
    358 / 361 (99.17%)
         occurrences all number
    458
    358
    Gastrointestinal disorders
    Gastro-intestinal disorders
         subjects affected / exposed
    365 / 458 (79.69%)
    305 / 361 (84.49%)
         occurrences all number
    365
    305
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    9 / 458 (1.97%)
    4 / 361 (1.11%)
         occurrences all number
    9
    4
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    138 / 458 (30.13%)
    115 / 361 (31.86%)
         occurrences all number
    138
    115
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    31 / 458 (6.77%)
    16 / 361 (4.43%)
         occurrences all number
    31
    16
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    198 / 458 (43.23%)
    145 / 361 (40.17%)
         occurrences all number
    198
    145
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    70 / 458 (15.28%)
    35 / 361 (9.70%)
         occurrences all number
    70
    35

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2011
    Version 2.0 (20 October 2011) Removal of LH dosage in men under the age of 45 and participating in the fertility study.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30658935
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