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    Clinical Trial Results:
    Dose-escalating and cohort expansion safety trial of tissue factor specific antibody drug conjugate tisotumab vedotin (HuMax®-TF-ADC) in patients with locally advanced and/or metastatic solid tumors known to express tissue factor

    Summary
    EudraCT number
    2015-001120-29
    Trial protocol
    GB   DK   BE   HU  
    Global end of trial date
    13 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Dec 2018
    First version publication date
    26 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEN702
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02552121
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Genmab A/S
    Sponsor organisation address
    Kalvebod Brygge 43, Copenhagen V, Denmark, 1560
    Public contact
    Clinical Trial Information, Genmab A/S, +45 7020 2728, clinicaltrials@genmab.com
    Scientific contact
    Clinical Trial Information, Genmab A/S, +45 7020 2728, clinicaltrials@genmab.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
    13 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the tolerability of HuMax-TF-ADC dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.
    Protection of trial subjects
    This trial was conducted in compliance with independent ethics committee (IEC)/institutional review board (IRB) and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines - including Title 21 Part 56 of the United States of America (USA) Code of Federal Regulations (CFR) relating to IRBs and ICH GCP as described in the US Food and Drug Administration (FDA) CFR (21 CFR Part 50, 56, 312), in accordance with applicable regulations regarding clinical safety data management (E2A, E2B(R3)), European Community directives 2001/20, 2001/83, 2003/94 and 2005/28 as enacted into local law, and with ICH guidelines regarding scientific integrity (E4, E8, E9 and E10). In addition, this trial adhered to all local regulatory requirements and requirements for data protection.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Oct 2015
    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
    United States: 4
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Denmark: 5
    Worldwide total number of subjects
    33
    EEA total number of subjects
    29
    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)
    25
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    For the Dose Escalation, participants took part in the trial at 3 sites located in Denmark, the United Kingdom (UK), and the United States (USA) from 30 Nov 2015 until 10 Feb 2017. Cohort Expansion trial was performed at 10 sites located in Belgium, UK, Denmark, and the USA, from 16 Feb 2016 until the last patient visit on 13 Dec 2017.

    Pre-assignment
    Screening details
    Participants reported to the clinical study site for the eligibility screening within 21 days prior to the first study drug administration. 20 participants were screened and 9 were enrolled across 3 sites in Part 1 Dose Escalation. 51 participants were screened and 24 were enrolled across 10 sites for Part 2 Cohort Expansion.

    Period 1
    Period 1 title
    Part 1 and Part 2: Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
    Arm description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.9 mg/kg or 1.2 mg/kg intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Arm title
    Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Arm description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 0.9 mg/kg or 1.2 mg/kg intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Arm title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
    Arm description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1.2 mg/kg, the RP2D from the Dose Escalation phase, intravenous infusion over a minimum of 30 minutes 3q4wk. Due to the observed severe ocular toxicity, participants received 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, once every 3 weeks (1q3w).

    Arm title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Arm description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1.2 mg/kg, the RP2D from the Dose Escalation phase, intravenous infusion over a minimum of 30 minutes 3q4wk. Due to the observed severe ocular toxicity, participants received 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, 1q3w.

    Arm title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
    Arm description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1.2 mg/kg, the RP2D from the Dose Escalation phase, intravenous infusion over a minimum of 30 minutes 3q4wk. Due to the observed severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, 1q3w.

    Arm title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
    Arm description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1.2 mg/kg, the RP2D from the Dose Escalation phase, intravenous infusion over a minimum of 30 minutes 3q4wk. Due to the observed severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, 1q3w.

    Arm title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
    Arm description
    Participants with the indication of ovarian cancer received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, 1q3w.

    Arm title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Arm description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 2.0 mg/kg intravenous infusion over a minimum of 30 minutes, 1q3w.

    Number of subjects in period 1
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Started
    3
    6
    11
    3
    1
    5
    1
    3
    Completed
    0
    0
    0
    0
    0
    1
    0
    0
    Not completed
    3
    6
    11
    3
    1
    4
    1
    3
         Death
    -
    -
    1
    -
    -
    -
    -
    -
         Disease Progression
    2
    2
    3
    2
    1
    4
    -
    3
         Miscellaneous
    -
    1
    -
    -
    -
    -
    -
    -
         Investigator Judgment
    -
    2
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    6
    1
    -
    -
    -
    -
         Patient Choice
    -
    1
    1
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
    Reporting group description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Reporting group description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.

    Reporting group values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical Total
    Number of subjects
    3 6 11 3 1 5 1 3 33
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0 3 10 3 1 4 1 3 25
        From 65-84 years
    3 3 1 0 0 1 0 0 8
    Age continuous
    Units: years
        median (full range (min-max))
    69.0 (66.0 to 70.0) 61 (38.0 to 71.0) 59.0 (50.0 to 65.0) 55.0 (50.0 to 58.0) 46.0 (46.0 to 46.0) 48.0 (39.0 to 67.0) 59.0 (59.0 to 59.0) 48.0 (30.0 to 60.0) -
    Gender categorical
    Units: Subjects
        Female
    1 4 11 3 1 5 1 3 29
        Male
    2 2 0 0 0 0 0 0 4
    Race
    Units: Subjects
        White
    3 5 10 3 1 5 1 3 31
        Asian
    0 1 1 0 0 0 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0 1 0 0 0 0 0 1
        Not Hispanic or Latino
    3 6 10 3 1 5 1 3 32
    Weight
    Units: kg
        median (full range (min-max))
    80.0 (76.3 to 80.0) 67.5 (48.1 to 85.0) 66.8 (40.0 to 89.6) 55.2 (41.7 to 63.5) 57.8 (57.8 to 57.8) 72.0 (52.8 to 79.3) 96.8 (96.8 to 96.8) 65.3 (60.5 to 65.5) -
    Height
    Units: cm
        median (full range (min-max))
    171.0 (168.0 to 171.4) 162.0 (156.0 to 175.0) 159.0 (154.0 to 174.0) 157.0 (148.0 to 161.0) 160.6 (160.6 to 160.6) 168.0 (159 to 177.8) 170.5 (170.5 to 170.5) 161.0 (156.0 to 162.0) -
    Body Mass Index (BMI)
    Units: kg/m^2
        median (full range (min-max))
    27.4 (26.0 to 28.3) 25.5 (19.8 to 27.8) 26.4 (16.9 to 32.5) 22.4 (16.1 to 29.0) 22.4 (22.4 to 22.4) 24.0 (18.7 to 28.5) 33.3 (33.3 to 33.3) 24.9 (23.3 to 26.9) -

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
    Reporting group description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Reporting group description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes, 3q4wk. Due to severe ocular toxicity at the dosing schedule of 1.2 mg/kg 3q4wk, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.

    Reporting group title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, 1q3w; the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.

    Primary: Part 1: Number of Participants who Experience at Least One Adverse Event (AE)

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    End point title
    Part 1: Number of Participants who Experience at Least One Adverse Event (AE) [1] [2]
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
    End point type
    Primary
    End point timeframe
    Part 1 Dose Escalation Phase: Baseline to end of trial, a maximum of 24 weeks (+/- 7 days) post last dose.
    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: No formal statistical tests were performed for this trial
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    3
    6
    No statistical analyses for this end point

    Primary: Part 2: Number of Participants who Experience at Least One Adverse Event (AE)

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    End point title
    Part 2: Number of Participants who Experience at Least One Adverse Event (AE) [3] [4]
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
    End point type
    Primary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, approximately 36 weeks.
    Notes
    [3] - 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: No formal statistical tests were performed for this trial
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    11
    3
    1
    5
    0
    3
    No statistical analyses for this end point

    Primary: Part 1: Number of Participants who Experienced at Least One or More Serious Adverse Event (SAE)

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    End point title
    Part 1: Number of Participants who Experienced at Least One or More Serious Adverse Event (SAE) [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, maximum of 24 weeks (+/- 7 days) post last dose.
    Notes
    [5] - 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: No formal statistical tests were performed for this trial.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    1
    2
    No statistical analyses for this end point

    Primary: Part 2: Number of Participants who Experienced at Least One or More Serious Adverse Event (SAE)

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    End point title
    Part 2: Number of Participants who Experienced at Least One or More Serious Adverse Event (SAE) [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [7] - 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: No formal statistical tests were performed for this trial
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    9
    2
    0
    2
    0
    1
    No statistical analyses for this end point

    Primary: Part 1: Number of Participants who Experienced at Least One or More Infusion-related Adverse Events

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    End point title
    Part 1: Number of Participants who Experienced at Least One or More Infusion-related Adverse Events [9] [10]
    End point description
    An infusion-related AE was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to Tisotumab vedotin by the investigator.
    End point type
    Primary
    End point timeframe
    Part 1 Dose Escalation: Day 1, Day 8 & Day 15 (+1 day) until end of treatment, up to 48 weeks.
    Notes
    [9] - 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: No formal statistical tests were performed for this trial
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    2
    4
    No statistical analyses for this end point

    Primary: Part 2: Number of Participants who Experienced at Least One or More Infusion-related Adverse Events

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    End point title
    Part 2: Number of Participants who Experienced at Least One or More Infusion-related Adverse Events [11] [12]
    End point description
    An infusion-related AE was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to Tisotumab vedotin by the investigator.
    End point type
    Primary
    End point timeframe
    Part 2 Cohort Expansion: Day 1, Day 8 & Day 15 (+1 day) until end of trial, up to 36 weeks.
    Notes
    [11] - 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: No formal statistical tests were performed for this trial
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    4
    2
    1
    1
    0
    1
    No statistical analyses for this end point

    Primary: Part 1: Number of Participants who Experienced at Least One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events

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    End point title
    Part 1: Number of Participants who Experienced at Least One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events [13] [14]
    End point description
    End point type
    Primary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, a maximum of 24 weeks (+/- 7 days) post last dose.
    Notes
    [13] - 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: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    1
    3
    No statistical analyses for this end point

    Primary: Part 2: Number of Participants who Experienced at Least One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events

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    End point title
    Part 2: Number of Participants who Experienced at Least One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events [15] [16]
    End point description
    End point type
    Primary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [15] - 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: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    10
    2
    0
    3
    0
    1
    No statistical analyses for this end point

    Primary: Part 1: Number of Participants who Experienced at Least One or More Treatment-related Adverse Event

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    End point title
    Part 1: Number of Participants who Experienced at Least One or More Treatment-related Adverse Event [17] [18]
    End point description
    End point type
    Primary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, a maximum of 24 weeks (+/- 7 days) post last dose.
    Notes
    [17] - 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: No formal statistical tests were performed for this trial
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    3
    6
    No statistical analyses for this end point

    Primary: Part 2: Number of Participants who Experienced at Least One or More Treatment-related Adverse Event

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    End point title
    Part 2: Number of Participants who Experienced at Least One or More Treatment-related Adverse Event [19] [20]
    End point description
    End point type
    Primary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [19] - 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: No formal statistical tests were performed for this trial
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    9
    3
    1
    5
    0
    3
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants with Markedly Abnormal Laboratory Values  

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    End point title
    Part 1: Number of Participants with Markedly Abnormal Laboratory Values   [21]
    End point description
    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, a maximum of 24 weeks (+/- 7 days) post last dose.
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    0
    6
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants with Markedly Abnormal Laboratory Values

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    End point title
    Part 2: Number of Participants with Markedly Abnormal Laboratory Values [22]
    End point description
    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    5
    2
    0
    3
    1
    3
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants who Experienced a Skin Rash

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    End point title
    Part 1: Number of Participants who Experienced a Skin Rash [23]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, a maximum of 24 weeks (+/- 7 days) post last dose.
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    0
    4
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants who Experienced a Skin Rash

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    End point title
    Part 2: Number of Participants who Experienced a Skin Rash [24]
    End point description
    End point type
    Secondary
    End point timeframe
    Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    2
    0
    1
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants who Experienced a Bleeding Event

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    End point title
    Part 1: Number of Participants who Experienced a Bleeding Event [25]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline until end of treatment, up to 48 weeks.
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    3
    5
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants who Experienced a Bleeding Event

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    End point title
    Part 2: Number of Participants who Experienced a Bleeding Event [26]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    7
    3
    1
    5
    0
    2
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants who Experienced a Neuropathy Event

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    End point title
    Part 1: Number of Participants who Experienced a Neuropathy Event [27]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline until end of treatment, up to 48 weeks.
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    1
    3
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants who Experienced a Neuropathy Event

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    End point title
    Part 2: Number of Participants who Experienced a Neuropathy Event [28]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    3
    1
    0
    2
    0
    1
    No statistical analyses for this end point

    Secondary: Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab vedotin (HuMax-TF-ADC) [29]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: h*µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    3336 ± 7.3
    5317 ± 34.6
        Cycle 1 Day 1
    867 ± 17.6
    1328 ± 48.0
        Cycle 1 Day 8
    1603 ± 16.2
    2216 ± 11.7
        Cycle 1 Day 15
    789 ± 15.6
    1411 ± 94.2
    No statistical analyses for this end point

    Secondary: Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab vedotin (HuMax-TF-ADC) [30]
    End point description
    9999 has been recorded when there is no data available for the data point. Arms only included 1 participant, no Geometric Coefficient of Variation could be calculated.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [31]
    3 [32]
    Units: h*µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    2267 ± 24.8
    1755 ± 19.1
        Cycle 1 Dose 1
    1889 ± 29.3
    1412 ± 11.9
        Cycle 1 Dose 2
    150 ± 56.2
    123 ± 85.4
        Cycle 1 Dose 3
    410 ± 26.4
    204 ± 71.3
    Notes
    [31] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [32] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Tisotumab vedotin (HuMax-TF-ADC) [33]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline until end of treatment, up to 48 weeks.
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    2
    4
    Units: h*µg/mL
        geometric mean (geometric coefficient of variation)
    920 ± 3.6
    1106 ± 21.3
    No statistical analyses for this end point

    Secondary: Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC) [34]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, up to 48 weeks.
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    21.2 ± 14.5
    30.7 ± 10.1
        Cycle 1 Day 1
    20.2 ± 17.9
    28.7 ± 12.1
        Cycle 1 Day 8
    20.9 ± 14.1
    28.0 ± 8.9
        Cycle 1 Day 15
    19.9 ± 11.8
    26.8 ± 21.6
    No statistical analyses for this end point

    Secondary: Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC) [35]
    End point description
    9999 has been recorded when there is no data available for the data point. Arms only included 1 participant, no Geometric Coefficient of Variation could be calculated. 9999 has been entered For Arms 'Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian' and 'Part 2 Cohort Expansion: Cohort 6 1q3w Cervical'; as data is only available at Cycle 1 due to changes in dosing schedule. Participants in these arms are only dosed once every 3 weeks (1q3wk).
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [36]
    3 [37]
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    28.2 ± 34.5
    19.5 ± 17.6
        Cycle 1 Dose 1
    28.2 ± 34.5
    19.5 ± 17.6
        Cycle 1 Dose 2
    1.00 ± 42.0
    1.13 ± 112.2
        Cycle 1 Dose 3
    3.85 ± 24.5
    1.85 ± 77.6
    Notes
    [36] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [37] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC) [38]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    5.864 ± 172.022
    5.061 ± 166.177
        Cycle 1 Day 1
    0.747 ± 11.547
    0.873 ± 79.228
        Cycle 1 Day 8
    0.717 ± 0
    0.846 ± 86.481
        Cycle 1 Day 15
    1.141 ± 81.075
    1.084 ± 73.110
    No statistical analyses for this end point

    Secondary: Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab vedotin (HuMax-TF-ADC) [39]
    End point description
    9999 has been recorded when there is no data available for the data point. Arms only included 1 participant, no Geometric Coefficient of Variation could be calculated. 9999 has been entered For Arms 'Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian' and 'Part 2 Cohort Expansion: Cohort 6 1q3w Cervical'; as data is only available at Cycle 1 due to changes in dosing schedule. Participants in these arms are only dosed once every 3 weeks (1q3wk).
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [40]
    3 [41]
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    0.75 ± 68.49
    0.58 ± 22.85
        Cycle 1 Dose 1
    0.75 ± 68.49
    0.58 ± 22.85
        Cycle 1 Dose 2
    165.06 ± 75.01
    106.93 ± 55.38
        Cycle 1 Dose 3
    71.23 ± 24.35
    80.37 ± 20.24
    Notes
    [40] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [41] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab vedotin (HuMax-TF-ADC) [42]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    4
    Units: hours
        geometric mean (geometric coefficient of variation)
    40.45 ± 24.78
    48.15 ± 16.47
    No statistical analyses for this end point

    Secondary: Part 1: Total Clearance (CL) of Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Total Clearance (CL) of Tisotumab vedotin (HuMax-TF-ADC) [43]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    2
    4
    Units: mL/h/kg
        geometric mean (geometric coefficient of variation)
    0.979 ± 3.561
    1.085 ± 21.476
    No statistical analyses for this end point

    Secondary: Part 1: Apparent Volume of Distribution (Vz) for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Apparent Volume of Distribution (Vz) for Tisotumab vedotin (HuMax-TF-ADC) [44]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    2
    4
    Units: mL/kg
        geometric mean (geometric coefficient of variation)
    66.75 ± 6.67
    75.37 ± 14.89
    No statistical analyses for this end point

    Secondary: Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab vedotin (HuMax-TF-ADC)

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    End point title
    Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab vedotin (HuMax-TF-ADC) [45]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1
    30.0 ± 0
    30.0 ± 0
        Cycle 1 Day 8
    797.3 ± 22.1
    1328.5 ± 191.8
        Cycle 1 Day 15
    912.1 ± 23.7
    989.0 ± 44.3
    No statistical analyses for this end point

    Secondary: Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Cojugated and Non-conjugated) [46]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: h*µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    3916 ± 7.3
    5573 ± 15.0
        Cycle 1 Day 1
    1058 ± 15.0
    1530 ± 34.7
        Cycle 1 Day 8
    1750 ± 16.2
    2460 ± 8.5
        Cycle 1 Day 15
    1012 ± 25.7
    1426 ± 28.6
    No statistical analyses for this end point

    Secondary: Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Cojugated and Non-conjugated) [47]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2: Baseline to end of trial (Part 2), up to 36 weeks
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [48]
    3 [49]
    Units: h*µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    2660 ± 20.0
    1948 ± 35.2
        Cycle 1 Dose 1
    1980 ± 24.5
    460 ± 84.5
        Cycle 1 Dose 2
    299 ± 55.0
    192 ± 80.9
        Cycle 1 Dose 3
    679 ± 25.7
    291 ± 89.9
    Notes
    [48] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [49] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Cojugated and Non-conjugated) [50]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    2
    6
    Units: h*µg/mL
        geometric mean (geometric coefficient of variation)
    1268 ± 14.4
    1594 ± 24.6
    No statistical analyses for this end point

    Secondary: Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Cojugated and Non-conjugated) [51]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    22.1 ± 9.1
    31.7 ± 11.9
        Cycle 1 Day 1
    20.3 ± 14.3
    30.2 ± 11.5
        Cycle 1 Day 8
    21.0 ± 6.3
    29.2 ± 6.6
        Cycle 1 Day 15
    20.9 ± 12.0
    29.2 ± 16.2
    No statistical analyses for this end point

    Secondary: Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

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    End point title
    Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated) [52]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2: Baseline to end of trial (Part 2) up to 36 weeks
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [53]
    3 [54]
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    27.5 ± 36.4
    20.6 ± 18.6
        Cycle 1 Dose 1
    27.5 ± 36.4
    20.6 ± 18.6
        Cycle 1 Dose 2
    2.00 ± 41.6
    1.91 ± 105.0
        Cycle 1 Dose 3
    6.39 ± 24.6
    3.68 ± 66.1
    Notes
    [53] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [54] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Cojugated and Non-conjugated) [55]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    36.445 ± 99.474
    14.003 ± 117.534
        Cycle 1 Day 1
    0.747 ± 11.547
    0.893 ± 66.752
        Cycle 1 Day 8
    0.717 ± 0
    0.869 ± 78.568
        Cycle 1 Day 15
    0.727 ± 4.784
    0.896 ± 78.665
    No statistical analyses for this end point

    Secondary: Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)

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    End point title
    Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated) [56]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2: Baseline to end of trial (Part 2), up to 36 weeks
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [57]
    3 [58]
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    0.86 ± 73.61
    0.58 ± 22.85
        Cycle 1 Dose 1
    0.86 ± 73.61
    0.58 ± 22.85
        Cycle 1 Dose 2
    165.06 ± 75.01
    106 ± 55.38
        Cycle 1 Dose 3
    71.23 ± 24.35
    80.37 ± 20.24
    Notes
    [57] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [58] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Cojugated and Non-conjugated) [59]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: hours
        geometric mean (geometric coefficient of variation)
    49.56 ± 17.35
    49.34 ± 19.18
    No statistical analyses for this end point

    Secondary: Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)

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    End point title
    Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated) [60]
    End point description
    CL could not be estimated for Part 1 or Part 2 participants due to insufficient samples taken.
    End point type
    Secondary
    End point timeframe
    Part 1 & Part 2: Baseline to end of trial (Part 1 & Part 2), approximately 21 months
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: CL could not be calculated, therefore no data is present.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    Units: mL/h/kg
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    ±
    Notes
    [61] - CL could not be estimated.
    [62] - CL could not be estimated.
    [63] - CL could not be estimated.
    [64] - CL could not be estimated.
    No statistical analyses for this end point

    Secondary: Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)

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    End point title
    Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated) [65]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1: Baseline to end of treatment, up to 48 weeks
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1
    150.0 ± 0
    150.0 ± 0
        Cycle 1 Day 8
    1273.1 ± 23.4
    1252.2 ± 53.3
        Cycle 1 Day 15
    1625.1 ± 24.4
    1863.8 ± 46.6
    No statistical analyses for this end point

    Secondary: Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Cojugated and Non-conjugated)

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    End point title
    Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Cojugated and Non-conjugated) [66]
    End point description
    Vz/F could not be estimated for Part 1 or Part 2 participants due to insufficient samples taken.
    End point type
    Secondary
    End point timeframe
    Part 1 & Part 2: Baseline to end of trial (Part 1 & Part 2), approximately 21 months
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Vz could not be calculated, therefore no data is present.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    0 [67]
    0 [68]
    0 [69]
    0 [70]
    Units: mL/kg
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    ±
    Notes
    [67] - Vz/F could not be estimated.
    [68] - Vz/F could not be estimated.
    [69] - Vz/F could not be estimated.
    [70] - Vz/F could not be estimated.
    No statistical analyses for this end point

    Secondary: Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for free toxin (MMAE)

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    End point title
    Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for free toxin (MMAE) [71]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    885 ± 27.1
    968 ± 59.7
        Cycle 1 Day 1
    185 ± 48.1
    185 ± 75.3
        Cycle 1 Day 8
    180 ± 14.1
    236 ± 75.5
        Cycle 1 Day 15
    506 ± 25.3
    520 ± 51.3
    No statistical analyses for this end point

    Secondary: Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for free toxin (MMAE)

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    End point title
    Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for free toxin (MMAE) [72]
    End point description
    9999 has been recorded when there is no data available for the data point. Arms only included 1 participant, no Geometric Coefficient of Variation could be calculated. 9999 has been entered For Arms 'Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian' and 'Part 2 Cohort Expansion: Cohort 6 1q3w Cervical'; as data is only available at Cycle 1 due to changes in dosing schedule. Participants in these arms are only dosed once every 3 weeks (1q3wk).
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [73]
    3 [74]
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    920 ± 74.5
    1049 ± 89.4
        Cycle 1 Dose 1
    439 ± 69.3
    393 ± 100.0
        Cycle 1 Dose 2
    378 ± 121.3
    366 ± 77.9
        Cycle 1 Dose 3
    713 ± 49.9
    494 ± 121.7
    Notes
    [73] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [74] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Cmax: Maximum Observed Plasma Concentration for free toxin (MMAE)

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    End point title
    Part 1: Cmax: Maximum Observed Plasma Concentration for free toxin (MMAE) [75]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    2.76 ± 23.7
    2.88 ± 52.4
        Cycle 1 Day 1
    1.46 ± 54.7
    1.38 ± 78.4
        Cycle 1 Day 8
    1.18 ± 19.8
    1.54 ± 75.4
        Cycle 1 Day 15
    2.76 ± 23.7
    2.88 ± 52.4
    No statistical analyses for this end point

    Secondary: Part 2: Cmax: Maximum Observed Plasma Concentration for free toxin (MMAE)

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    End point title
    Part 2: Cmax: Maximum Observed Plasma Concentration for free toxin (MMAE) [76]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [77]
    3 [78]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    3.9 ± 97.0
    3.6 ± 101.4
        Cycle 1 Dose 1
    1.9 ± 110.5
    1.5 ± 80.4
        Cycle 1 Dose 2
    2.47 ± 136.4
    2.50 ± 81.1
        Cycle 1 Dose 3
    3.78 ± 81.6
    3.23 ± 125.0
    Notes
    [77] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n = 6
    [78] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for free toxin (MMAE)

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    End point title
    Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for free toxin (MMAE) [79]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    392.024 ± 3.256
    373.366 ± 6.290
        Cycle 1 Day 1
    44.568 ± 114.567
    32.001 ± 125.788
        Cycle 1 Day 8
    10.354 ± 165.509
    20.837 ± 106.094
        Cycle 1 Day 15
    54.511 ± 20.424
    32.537 ± 63.879
    No statistical analyses for this end point

    Secondary: Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for free toxin (MMAE)

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    End point title
    Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for free toxin (MMAE) [80]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Number of subjects analysed
    11 [81]
    3 [82]
    Units: hours
    geometric mean (geometric coefficient of variation)
        Cycle 1
    307.05 ± 36.52
    410.61 ± 3.82
        Cycle 1 Dose 1
    160.56 ± 5.66
    162.19 ± 1.71
        Cycle 1 Dose 2
    164.82 ± 56.71
    106.93 ± 55.38
        Cycle 1 Dose 3
    78.37 ± 50.26
    80.37 ± 20.24
    Notes
    [81] - Cycle 1 Dose 2: n = 9 Cycle 1 Dose 3: n - 6
    [82] - Cycle 1 Dose 3: n = 2
    No statistical analyses for this end point

    Secondary: Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for free toxin (MMAE)

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    End point title
    Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for free toxin (MMAE) [83]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: pg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1
    12.50 ± 0
    12.50 ± 0
        Cycle 1 Day 8
    853.42 ± 22.93
    1061.28 ± 87.81
        Cycle 1 Day 15
    1013.22 ± 14.47
    1384.29 ± 83.43
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants with a Positive Anti-drug antibody (ADA) Immunogenicity Result

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    End point title
    Part 1: Number of Participants with a Positive Anti-drug antibody (ADA) Immunogenicity Result [84]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of trial, up to 48 weeks.
    Notes
    [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants with a Positive Anti-drug antibody (ADA) Immunogenicity Result

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    End point title
    Part 2: Number of Participants with a Positive Anti-drug antibody (ADA) Immunogenicity Result [85]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part 1: Number of Patients who experienced anti-tumor activity measured by tumor shrinkage

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    End point title
    Part 1: Number of Patients who experienced anti-tumor activity measured by tumor shrinkage [86]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
    1
    3
    No statistical analyses for this end point

    Secondary: Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements

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    End point title
    Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements [87]
    End point description
    9999 has been used when there is no data. As the arm only includes 1 participants, there is no Standard Deviation data to enter.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: percent
        arithmetic mean (standard deviation)
    -17.34 ± 43.388
    32.78 ± 83.933
    -63.27 ± 9999
    0.74 ± 21.877
    0 ± 9999
    11.76 ± 27.658
    No statistical analyses for this end point

    Secondary: Part 1: Response Evaluation based on PSA (Prostate specific antigen [Prostate Cancer]): Percentage of Change from Baseline to End of Study 

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    End point title
    Part 1: Response Evaluation based on PSA (Prostate specific antigen [Prostate Cancer]): Percentage of Change from Baseline to End of Study  [88]
    End point description
    9999 has been recorded when there is no data to enter for a data point. As only 1 participant is included in the data set, there is no Standard Deviation.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline until end of treatment, up to 48 weeks.
    Notes
    [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    2
    1
    Units: percent
        arithmetic mean (standard deviation)
    23.42 ± 61.686
    12.97 ± 9999
    No statistical analyses for this end point

    Secondary: Part 1: Response Evaluation based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial cancer]): Percentage of Change from Baseline to End of Study 

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    End point title
    Part 1: Response Evaluation based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial cancer]): Percentage of Change from Baseline to End of Study  [89]
    End point description
    9999 has been recorded when there is no data to enter for a data point. Only 1 participant is included in the arm, so no Standard Deviation could be calculated.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    0 [90]
    1
    Units: percent
        arithmetic mean (standard deviation)
    ±
    186.21 ± 9999
    Notes
    [90] - No participants with the indication of Ovarian or Endometrial Cancer had results at the End of Study
    No statistical analyses for this end point

    Secondary: Part 2: Response Evaluation based on CA125 (Ovarian and Endometrial cancer): Percentage of Change from Baseline to End of Study

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    End point title
    Part 2: Response Evaluation based on CA125 (Ovarian and Endometrial cancer): Percentage of Change from Baseline to End of Study [91]
    End point description
    9999 has been recorded when there is no data to recorded for a data point. As only 1 participant was included in the arm, no Standard Deviation could be calculated.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [91] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    8
    0 [92]
    1
    0 [93]
    0 [94]
    0 [95]
    Units: percent
        arithmetic mean (standard deviation)
    -31.75 ± 36.235
    ±
    -32.50 ± 9999
    ±
    ±
    ±
    Notes
    [92] - CA125 was assessed in patients with ovarian or endometrial cancer only.
    [93] - CA125 was assessed in patients with ovarian or endometrial cancer only.
    [94] - No participants with the indication of Ovarian Cancer had results at End of Study.
    [95] - CA125 was assessed in patients with ovarian or endometrial cancer only.
    No statistical analyses for this end point

    Secondary: Part 1: Best Overall Response (OR)

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    End point title
    Part 1: Best Overall Response (OR) [96]
    End point description
    Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment (Part 1), up to 48 weeks
    Notes
    [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
        Complete Response
    0
    0
        Partial Response
    0
    1
        Stable Disease
    2
    3
        Progressive Disease
    1
    1
        Not Evaluable
    0
    1
    No statistical analyses for this end point

    Secondary: Part 2: Best Overall Response (OR)

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    End point title
    Part 2: Best Overall Response (OR) [97]
    End point description
    Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial (Part 2), up to 36 weeks
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical tests were performed for this trial
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
        Complete Response
    0
    0
    0
    0
    0
    0
        Partial Response
    3
    1
    1
    2
    0
    0
        Stable Disease
    3
    0
    0
    2
    0
    2
        Progressive Disease
    2
    2
    0
    1
    1
    1
        Not Evaluable
    3
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part 1: Number of Participants who experienced Disease Control  

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    End point title
    Part 1: Number of Participants who experienced Disease Control   [98]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: 6, 12, 24 and 36 weeks post first dose.
    Notes
    [98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: Participants
        6 Weeks
    2
    3
        12 Weeks
    0
    0
        24 Weeks
    0
    0
        36 Weeks
    0
    0
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants who experienced Disease Control

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    End point title
    Part 2: Number of Participants who experienced Disease Control [99]
    End point description
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: 6, 12, 24 and 36 weeks post first dose.
    Notes
    [99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: Participants
        6 Weeks
    6
    1
    1
    4
    0
    2
        12 Weeks
    2
    1
    1
    2
    0
    1
        24 Weeks
    0
    0
    0
    1
    0
    0
        36 Weeks
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part 1: Proportion of Patients with Progression Free Survival 

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    End point title
    Part 1: Proportion of Patients with Progression Free Survival  [100]
    End point description
    Based on target lesions, progressive disease was defined as ≥ 20% (and ≥ 5 m m) increase in the sum of the LDs of target lesions, taking as reference the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions. Based on non-target lesions, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The proportion of patients with PFS will be summarized using Kaplan-Meier estimates.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: 12, 24, 36, 48 and 60 Weeks Post first dose.
    Notes
    [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    3
    6
    Units: percentage of participants
    number (not applicable)
        12 Weeks
    50
    67
        24 Weeks
    0
    67
        36 Weeks
    0
    67
        48 Weeks
    0
    67
        60 Weeks
    0
    67
    No statistical analyses for this end point

    Secondary: Part 2: Proportion of Patients with Progression Free Survival

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    End point title
    Part 2: Proportion of Patients with Progression Free Survival [101]
    End point description
    Based on target lesions, progressive disease was defined as ≥ 20% (and ≥ 5 m m) increase in the sum of the LDs of target lesions, taking as reference the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions. Based on non-target lesions, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The proportion of patients with PFS will be summarized using Kaplan-Meier estimates.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: 12, 24 and 36 weeks post first dose.
    Notes
    [101] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    11
    3
    1
    5
    1
    3
    Units: percentage of participants
    number (not applicable)
        12 Weeks
    39
    33
    100
    60
    0
    33
        24 Weeks
    39
    33
    0
    20
    0
    0
        36 Weeks
    39
    33
    0
    20
    0
    0
    No statistical analyses for this end point

    Secondary: Part 1: Duration of Response

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    End point title
    Part 1: Duration of Response [102]
    End point description
    Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death. Duration of Response could not be estimated as participants with a confirmed response were discontinued due to toxicity or other reason different from PD or death.
    End point type
    Secondary
    End point timeframe
    Part 1 Dose Escalation: Baseline to end of treatment, up to 48 weeks.
    Notes
    [102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 1 is displayed for this endpoint.
    End point values
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
    Number of subjects analysed
    0 [103]
    0 [104]
    Units: Weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [103] - Duration of response could not be calculated due to insufficient number of participants.
    [104] - 1 participant was responder but DOR was censored, therefore duration of response was not calculated
    No statistical analyses for this end point

    Secondary: Part 2: Duration of Response

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    End point title
    Part 2: Duration of Response [105]
    End point description
    Duration of response was defined as as the number of days from the first documentation of objective tumor response (CR or PR) to the date of first PD or death. Duration of Response could not be estimated as patients with a confirmed response were discontinued due to toxicity or other reason different from PD or death.
    End point type
    Secondary
    End point timeframe
    Part 2 Cohort Expansion: Baseline to end of trial, up to 36 weeks.
    Notes
    [105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Study was conducted in 2 parts; Part 1 Dose Escalation and Part 2 Cohort Expansion. Only data for Part 2 is displayed for this endpoint.
    End point values
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Number of subjects analysed
    0 [106]
    0 [107]
    0 [108]
    0 [109]
    0 [110]
    0 [111]
    Units: Weeks
        number (not applicable)
    Notes
    [106] - Duration of response could not be calculated as participants discontinued.
    [107] - Duration of response could not be calculated as participants discontinued.
    [108] - Duration of response could not be calculated as participants discontinued.
    [109] - Duration of response could not be calculated as participants discontinued.
    [110] - Duration of response could not be calculated as participants discontinued.
    [111] - Duration of response could not be calculated as participants discontinued.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to End of Trial (Part 1 &2), approximately 21 Months.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Part 1: Dose Escalation: Cohort 1 0.9mg/kg
    Reporting group description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 1: Dose Escalation: Cohort 2 1.2 mg/kg
    Reporting group description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials [RP2D] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants continued to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants continued to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
    Reporting group description
    Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w).

    Reporting group title
    Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Reporting group description
    Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w).

    Serious adverse events
    Part 1: Dose Escalation: Cohort 1 0.9mg/kg Part 1: Dose Escalation: Cohort 2 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    9 / 11 (81.82%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    2 / 5 (40.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Symblepharon
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    4 / 11 (36.36%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    4 / 4
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nauea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic pseudo-obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    3 / 11 (27.27%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    3 / 3
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part 1: Dose Escalation: Cohort 1 0.9mg/kg Part 1: Dose Escalation: Cohort 2 1.2 mg/kg Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    11 / 11 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    5 / 5 (100.00%)
    0 / 1 (0.00%)
    3 / 3 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 6 (33.33%)
    6 / 11 (54.55%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    4 / 5 (80.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    2
    2
    8
    1
    1
    6
    0
    3
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Radiation proctitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Vital dye staining cornea present
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Urine output increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    3 / 3 (100.00%)
    5 / 6 (83.33%)
    7 / 11 (63.64%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    4
    5
    8
    1
    1
    3
    0
    5
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Laryngeal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nasal dryness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    4
    2
    0
    2
    0
    2
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 6 (66.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    4
    1
    0
    0
    1
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    0
    1
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    0
    Polyneuropathy
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    7
    0
    0
    3
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    1
    Keratitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 5 (40.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    4
    0
    0
    Meibomianitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Symblepharon
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Punctate keratitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Episcleritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Keratopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Ulcerative keratitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    3 / 11 (27.27%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    4 / 5 (80.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    0
    3
    4
    1
    0
    6
    0
    2
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 6 (66.67%)
    5 / 11 (45.45%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    2 / 5 (40.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    5
    5
    1
    0
    2
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 6 (50.00%)
    4 / 11 (36.36%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    4
    0
    1
    4
    0
    0
    Nausea
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 6 (33.33%)
    5 / 11 (45.45%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    2
    6
    1
    1
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    4 / 11 (36.36%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    6
    1
    0
    1
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Lip ulceration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Rectal discharge
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Tongue blistering
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    0
    4
    0
    1
    0
    0
    0
    4
    Acute kidney injury
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cystitis noninfective
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    5 / 11 (45.45%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
         occurrences all number
    0
    1
    5
    1
    1
    3
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    1
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    3
    0
    0
    1
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 6 (50.00%)
    3 / 11 (27.27%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    3
    3
    1
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 5 (40.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    2 / 5 (40.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 6 (50.00%)
    5 / 11 (45.45%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    4
    5
    1
    1
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    3
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    Cell death
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    2 / 3 (66.67%)
    6 / 6 (100.00%)
    5 / 11 (45.45%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    3 / 5 (60.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    2
    12
    6
    0
    0
    6
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 11 (9.09%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    1
    1
    1
    0
    2
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 11 (18.18%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    1 / 5 (20.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Escherichia vaginitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 5 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection