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    Clinical Trial Results:
    Phase II, open-label, non-randomized study of nab-paclitaxel for the neoadjuvant treatment of patients with stage II and III luminal breast cancer.

    Summary
    EudraCT number
    		 2011-004476-10
    Trial protocol
    		 ES  
    Global end of trial date
    27 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2020
    First version publication date
    17 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEICAM/2011-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01565499
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GEICAM (FUNDACIÓN GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA)
    Sponsor organisation address
    Avenida de los Pirineos 7, San Sebastián de los Reyes / Madrid, Spain, 28703
    Public contact
    GEICAM, GEICAM, +34 916592870, inicio_ensayos@geicam.org
    Scientific contact
    GEICAM, GEICAM, +34 916592870, inicio_ensayos@geicam.org
    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
    17 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.
    Protection of trial subjects
    Not applicable. It was not necessary to applied extra measures for protection of the subjects out of the good clinical practice environment.
    Background therapy
    		 The use of chemotherapy in the neoadjuvant setting is a good treatment choice for either premenopausal ER positive patients, or patients with high Ki-67. nab-Paclitaxel is a novel formulation of paclitaxel that consists of nanometer-range particles of paclitaxel bound of human serum albumin. nab-Paclitaxel exploits the role of of albumin as the natural carrier of hidrofobic molecules in human to increase paclitaxel delivery to tumor cells, eliminating the need for solvents. nab-Paclitaxel (every three weeks) showed a significant higher ORR and longer TTP than standard paclitaxel (every three weeks) in a phase III study in metastatic breast cancer. Weekly nab-Paclitaxel also demonstrated a superior efficacy and safety than every three weeks docetaxel in a randomized phase II study. The nab-paclitaxel weekly dose of 150 mg/m2 appeared to be the most effective. This study proposes evaluating the activity and safety profile of weekly nab-paclitaxel administered at a dose of 150 mg/m2 (on days 1,8 and 15 every four weeks) for 4 cycles cycles as the neoadjuvant treatment of women with positive estrogen receptors and negative HER2, amenable to receive chemotherapy. Likewise, biomarkers will be investigated for the purpose of aiding and improving the understanding of the efficacy, safety and mechanism of action of nab-paclitaxel in these patients.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    73
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between April 2012 and January 2013, 83 patients were registered in 15 Spanish sites. Two of them never received treatment and were excluded from the analysis, so the number of subjects enrolled is 81.

    Pre-assignment
    Screening details
    		 Between April 2012 and January 2013, 83 patients were registered in 15 Spanish sites. Two of them never received treatment and were excluded from the analysis, so the number of subjects enrolled is 81.

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

    Arms
    Arm title
    		 Nab-Paclitaxel
    Arm description
    		 The patients were included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. There are 2 patients that have not received any cycle and they are excluded of analysis by Intention to Treat (ITT) criterium: One does not receive any cycle, she ended treatment by investigator´s criterium and the other withdraws informed consent before starting the treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Treatment Administered: nab-Paclitaxel: administered at a dose of 150 mg/m2 as a 30 minutes intravenous infusion on days 1, 8 and 15 in cycles of 28 days for 4 cycles.

    Number of subjects in period 1
    		Nab-Paclitaxel
    Started
    81
    Completed
    75
    Not completed
    6
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 The patients were included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. There are 2 patients that have not received any cycle and they are excluded of analysis by Intention to Treat (ITT) criterium: One does not receive any cycle, she ended treatment by investigator´s criterium and the other withdraws informed consent before starting the treatment.

    Reporting group values
    		 Nab-Paclitaxel Total
    Number of subjects
    		 81 81
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 73 73
        From 65-84 years
    		 8 8
    Age continuous
    Units: years
        median (full range (min-max))
    		 47 (28 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 81 81
        Male
    		 0 0
    Race
    Units: Subjects
        Caucasian
    		 79 79
        Hispanic
    		 2 2
    Menopausal Status
    Units: Subjects
        Postmenopausal
    		 29 29
        Premenopausal
    		 52 52
    Hormonal status
    Units: Subjects
        Estrogen Receptor (ER) (+) and Progesterone R (+)
    		 62 62
        ER (+) and Progesterone R (-)
    		 17 17
        ER (+) and Progesterone R (Not available)
    		 2 2
    Clinical Stage
    Measure Description: According to American Joint Committee on Cancer (AJCC) 2002: • Stage (S) I: tumour <2 centimetres (cm) • S II: S IIA: cancer spread to movable ipsilateral axillary (MIA) Lymph Nodes (LN). tumor <2 cm and spread to MIA LN tumor >2 cm but >5 cm S IIB: tumor >2 cm but <5 cm and spread to MIA LN tumor >5 cm • S III: S IIIA: cancer spread to ipsilateral axillary LN fixed or matted S IIIB: tumor spread to the chest wall or caused swelling or ulceration of the breast or is diagnosed as inflammatory breast cancer. S IIIC: metastases in ipsilateral infraclavicular LN.
    Units: Subjects
        Stage I
    		 4 4
        Stage II
    		 56 56
        Stage III
    		 18 18
        Unknown
    		 3 3
    Histopathologic Grade
    Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells. • G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue. • G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3. • G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster.
    Units: Subjects
        Grade 1
    		 9 9
        Grade 2
    		 39 39
        Grade 3
    		 26 26
        Unknown
    		 7 7
    Breast Surgery Planned
    Units: Subjects
        Mastectomy
    		 50 50
        Quadrantectomy
    		 17 17
        Lumpectomy
    		 10 10
        Not available
    		 4 4
    Eastern Cooperative Oncology Group (ECOG) status
    Units: Subjects
        ECOG 0
    		 79 79
        ECOG 1
    		 2 2
    Histopathologic Type
    Units: Subjects
        Infiltrating Ductal Carcinoma
    		 74 74
        Infiltrating Lobular Carcinoma
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 The patients were included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles. There are 2 patients that have not received any cycle and they are excluded of analysis by Intention to Treat (ITT) criterium: One does not receive any cycle, she ended treatment by investigator´s criterium and the other withdraws informed consent before starting the treatment.

    Primary: The Residual Cancer Burden Grade III (RCB-III)

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    End point title
    		 The Residual Cancer Burden Grade III (RCB-III) [1]
    End point description
    The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population
    End point type
    Primary
    End point timeframe
    After surgery, up to 4 months
    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: The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    81
    Units: Count of Participants
    23
    No statistical analyses for this end point

    Secondary: Pathologic Complete Response (pCR) Rate

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    End point title
    		 Pathologic Complete Response (pCR) Rate
    End point description
    The estimate of the pCR rate was calculated as follows by central laboratory: pCR Rate = Number of patients with pCR / ITT population.
    End point type
    Secondary
    End point timeframe
    After surgery, up to 4 months
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    81
    Units: Count of Participants
    6
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)

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    End point title
    		 Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)
    End point description
    The estimate of the ORR was determined according to RECIST 1.1 and measured by MRI and mammogram in patients treated with this regimen. ORR was calculated as follows: Overall Response Rate = Number of Complete Responses (CRs), Partial Responses (PRs) / ITT population
    End point type
    Secondary
    End point timeframe
    After surgery, up to 4 months
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    81
    Units: Count of participants
    62
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) by Mammogram

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    End point title
    		 Objective Response Rate (ORR) by Mammogram
    End point description
    The ORR was reported including a 95% confidence interval. The estimate of the ORR was determined according to RECIST 1.1 and measured by MRI and mammogram in patients treated with this regimen. ORR was calculated as follows: Overall Response Rate = Number of CRs, PRs / ITT population
    End point type
    Secondary
    End point timeframe
    After surgery, up to 4 months
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    81
    Units: Count of Participants
    49
    No statistical analyses for this end point

    Secondary: Invasive Disease Free Survival (IDFS)

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    End point title
    		 Invasive Disease Free Survival (IDFS)
    End point description
    IDFS was defined as the time (days) from the date of randomization until the date of objective recurrent disease (local, regional or distant), second primary invasive malignancy (breast or non-breast) or death from any cause. For patients not known to have died as of the data cut-off date and who do not have recurrent disease or second primary tumor, invasive disease-free survival will be censored at the last contact date. Ductal carcinoma in-situ (DCIS) will not be considered an event for the purpose of this analysis.
    End point type
    Secondary
    End point timeframe
    After surgery, up to 4 months
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    81
    Units: Years
        median (standard deviation)
    4.89 ( 1.10 )
    Attachments
    		 Invasive Disease Free Survival
    No statistical analyses for this end point

    Secondary: Rate of Conversion to Breast Conserving Surgery (BCS)

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    End point title
    		 Rate of Conversion to Breast Conserving Surgery (BCS)
    End point description
    The estimate of the rate of conversion to BCS was calculated as follows: BCS rate = Number of patients with BCS / Number of patients with initially planned mastectomy.
    End point type
    Secondary
    End point timeframe
    After surgery, up to 4 months
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    50
    Units: Patients with BCS
    20
    No statistical analyses for this end point

    Secondary: Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response

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    End point title
    		 Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
    End point description
    Ki67 was analysed by immunohistochemistry following the American Society of Clinical Oncology and the College of American Pathologists guidelines. The cut-off considered for Ki67 expression was 20% of positively stained tumor cells.
    End point type
    Secondary
    End point timeframe
    Baseline: in Pre-treatment Tumor Samples
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    72
    Units: Participants
    number (not applicable)
        ≥ 20 %
    40
        < 20 %
    32
    No statistical analyses for this end point

    Secondary: Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response

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    End point title
    		 Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
    End point description
    Caveolin (Cav)-1 was evaluated in the stroma and its expression was categorized in low, moderate, or high (tertile). The high expression of Cav-1 was considered as positive.
    End point type
    Secondary
    End point timeframe
    Baseline: Pre-treatment Tumor Samples
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    72
    Units: Participants
    number (not applicable)
        Positive
    19
        Negative
    53
    No statistical analyses for this end point

    Secondary: Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response

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    End point title
    		 Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response
    End point description
    SPARC was evaluated for both tumor and stroma. Its expression was categorized as negative when the intensity was absent-to-weak (1), or moderate (11)-to-strong (111) with a proportion of stained cells <10%. Immunolabeling was positive if the intensity was moderate (11)-to-strong (111) and the extent of staining was 10%.
    End point type
    Secondary
    End point timeframe
    Baseline: Pre-treatment Tumor Samples
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    72
    Units: Participants
    number (not applicable)
        Positive
    7
        Negative
    65
    No statistical analyses for this end point

    Secondary: Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response

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    End point title
    		 Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response
    End point description
    Molecular subtypes were classified according to St. Gallen criteria 2013 and Prat et al. into Luminal A (ER+, PgR >20%, HER2-, Ki67 <14%), Luminal B1 (ER+, HER2-, PgR >20% and/or Ki67 <14%), Luminal B2 (ER+, HER2+, any PgR, any Ki67), TN (ER-, PgR-, HER2-), and HER2-enriched (ER-, PgR-, HER2+) subtypes.
    End point type
    Secondary
    End point timeframe
    Baseline: Pre-treatment Tumor Samples
    End point values
    		 Nab-Paclitaxel
    Number of subjects analysed
    72
    Units: Participants
    number (not applicable)
        Luminal A
    19
        Luminal B1
    53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the date informed consent was signed, during treatment period, and for up 30 days after the last dose of each patient. Thereafter all study drug-related SAEs were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTC
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 -

    Serious adverse events
    		 Nab-Paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 81 (7.41%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Multiple Sclerosis Relapse
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Community-acquired pneumonia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Local Infection Reservoir Area
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nab-Paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 81 (100.00%)
    Investigations
    NEUTROPHIL COUNT DECREASED grade 3
         subjects affected / exposed
    10 / 81 (12.35%)
         occurrences all number
    10
    NEUTROPHIL COUNT DECREASED grade 2
         subjects affected / exposed
    22 / 81 (27.16%)
         occurrences all number
    22
    NEUTROPHIL COUNT DECREASED grade 1
         subjects affected / exposed
    21 / 81 (25.93%)
         occurrences all number
    21
    WHITE BLOOD CELL DECREASED grade 2
         subjects affected / exposed
    21 / 81 (25.93%)
         occurrences all number
    21
    WHITE BLOOD CELL DECREASED grade 1
         subjects affected / exposed
    29 / 81 (35.80%)
         occurrences all number
    29
    ALANINE AMINOTRANSFERASE INCREASED grade 1
         subjects affected / exposed
    32 / 81 (39.51%)
         occurrences all number
    32
    ALKALINE PHOSPHATASE INCREASED grade 1
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    ASPARTATE AMINOTRANSFERASE INCREASED grade 1
         subjects affected / exposed
    14 / 81 (17.28%)
         occurrences all number
    14
    CHOLESTEROL HIGH grade 1
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    HYPERCALCEMIA grade 1
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    HYPERGLYCEMIA grade 1
         subjects affected / exposed
    18 / 81 (22.22%)
         occurrences all number
    18
    Vascular disorders
    HYPERTENSION grade 3
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    HYPERTENSION grade 2
         subjects affected / exposed
    15 / 81 (18.52%)
         occurrences all number
    15
    HYPERTENSION grade 1
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    HOT FLASHES grade 1
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    Nervous system disorders
    PERIPHERAL SENSORY NEUROPATHY grade 2
         subjects affected / exposed
    22 / 81 (27.16%)
         occurrences all number
    22
    PERIPHERAL SENSORY NEUROPATHY grade 1
         subjects affected / exposed
    40 / 81 (49.38%)
         occurrences all number
    40
    DIZZINESS grade 1
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    DYSGEUSIA grade 1
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    HEADACHE grade 1
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    ANEMIA grade 2
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    ANEMIA grade 1
         subjects affected / exposed
    58 / 81 (71.60%)
         occurrences all number
    58
    ERITROCYTES DECREASE grade 1
         subjects affected / exposed
    10 / 81 (12.35%)
         occurrences all number
    10
    General disorders and administration site conditions
    FATIGUE grade 2
         subjects affected / exposed
    20 / 81 (24.69%)
         occurrences all number
    20
    FATIGUE grade 1
         subjects affected / exposed
    38 / 81 (46.91%)
         occurrences all number
    38
    EDEMA LIMBS grade 1
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    FEVER grade 1
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    PAIN IN EXTREMITY grade 1
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Gastrointestinal disorders
    CONSTIPATION grade 2
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    CONSTIPATION grade 1
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    DIARRHEA grade 2
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    DIARRHEA grade 1
         subjects affected / exposed
    23 / 81 (28.40%)
         occurrences all number
    23
    MUCOSITIS ORAL grade 1
         subjects affected / exposed
    13 / 81 (16.05%)
         occurrences all number
    13
    NAUSEA grade 1
         subjects affected / exposed
    23 / 81 (28.40%)
         occurrences all number
    23
    VOMITING grade 1
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Reproductive system and breast disorders
    IRREGULAR MENSTRUATION grade 2
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    BREAST PAIN grade 1
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    ALOPECIA grade 2
         subjects affected / exposed
    54 / 81 (66.67%)
         occurrences all number
    54
    ALOPECIA grade 1
         subjects affected / exposed
    12 / 81 (14.81%)
         occurrences all number
    12
    NAIL LOSS grade 2
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    NAIL LOSS grade 1
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    PRURITUS grade 1
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    NAIL CHANGES grade 1
         subjects affected / exposed
    14 / 81 (17.28%)
         occurrences all number
    14
    RASH grade 1
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    Psychiatric disorders
    DEPRESSION grade 1
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    INSOMNIA grade 1
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA grade 2
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    ARTHRALGIA grade 1
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    MYALGIA grade 2
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    MYALGIA grade 1
         subjects affected / exposed
    15 / 81 (18.52%)
         occurrences all number
    15
    BONE PAIN grade 1
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    Infections and infestations
    UPPER RESPIRATORY INFECTION grade 2
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    ANOREXIA grade 1
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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/28701571
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