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    Clinical Trial Results:
    A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of FOLFIRI + MEHD7945A versus FOLFIRI + Cetuximab in Second Line in Patients with KRAS Wild-Type Metastatic Colorectal Cancer

    Summary
    EudraCT number
    		 2011-005547-27
    Trial protocol
    		 DE   GB   BE   ES   IT  
    Global end of trial date
    26 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2016
    First version publication date
    26 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO28074
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01652482
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse124, Basel, Switzerland, CH-4070
    Public contact
    F.Hoffmann-LaRocheAG, Roche Trial Information Hotline, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F.Hoffmann-LaRocheAG, Roche Trial Information Hotline, +41 616878333, global.trial_information@roche.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
    26 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of folinic acid-fluorouracil-Irinotecan (FOLFIRI) + MEHD7945A versus FOLFIRI + cetuximab in participants with KRAS wild-type metastatic colorectal cancer (mCRC) and in participants with KRAS wild - type mCRC whose tumors expressed low levels of Human Epidermal Growth Factor Receptor 3 (HER3).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice (GCP) and investigators were trained according to applicable Sponsor standard operating procedures (SOPs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Australia: 27
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    New Zealand: 22
    Country: Number of subjects enrolled
    Romania: 3
    Worldwide total number of subjects
    134
    EEA total number of subjects
    63
    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)
    74
    From 65 to 84 years
    59
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participant screening was conducted from Day -14 to Day -1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FOLFIRI+ MEHD7945A
    Arm description
    		 Participants received MEHD7945A 1100 milligrams (mg) intravenous (IV) infusion every two weeks (14-day cycle) until unacceptable toxicity, documented disease progression or death. Participants also received 5 fluorouracil (5-FU) 400 milligrams per square meter (mg/m^2) as an IV bolus and then 5-FU 2400 mg/m^2 as a continuous IV infusion, irinotecan 180 milligrams per square meter (mg/m^2) IV infusion concurrently (using a y connector) with leucovorin 400 mg/m^2 (racemic form) or 200 mg/m^2 (L-isomer form) IV infusion (FOLFIRI) on Day 1 of 14-day continuous cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEHD7945A
    Investigational medicinal product code
    RO5541078
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1100 mg IV infusion every two weeks

    Arm title
    		 FOLFIRI + Cetuximab
    Arm description
    		 All participants received cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 IV infusion once a week until unacceptable toxicity, documented disease progression or death. Participants also received FOLFIRI on Day 1 of 14-day continuous cycles.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m^2 initial dose followed by 250 mg/m^2 IV infusion once a week

    Number of subjects in period 1
    		FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Started
    68
    66
    Completed
    0
    0
    Not completed
    68
    66
         Consent withdrawn by subject
    5
    3
         Randomized but not enrolled
    -
    1
         Death
    34
    33
         Study termination by sponsor
    28
    29
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FOLFIRI+ MEHD7945A
    Reporting group description
    		 Participants received MEHD7945A 1100 milligrams (mg) intravenous (IV) infusion every two weeks (14-day cycle) until unacceptable toxicity, documented disease progression or death. Participants also received 5 fluorouracil (5-FU) 400 milligrams per square meter (mg/m^2) as an IV bolus and then 5-FU 2400 mg/m^2 as a continuous IV infusion, irinotecan 180 milligrams per square meter (mg/m^2) IV infusion concurrently (using a y connector) with leucovorin 400 mg/m^2 (racemic form) or 200 mg/m^2 (L-isomer form) IV infusion (FOLFIRI) on Day 1 of 14-day continuous cycles.

    Reporting group title
    FOLFIRI + Cetuximab
    Reporting group description
    		 All participants received cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 IV infusion once a week until unacceptable toxicity, documented disease progression or death. Participants also received FOLFIRI on Day 1 of 14-day continuous cycles.

    Reporting group values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab Total
    Number of subjects
    		 68 66 134
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.9 ( 12.4 ) 61.8 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 19 51
        Male
    		 36 46 82
        Not recorded
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    FOLFIRI+ MEHD7945A
    Reporting group description
    		 Participants received MEHD7945A 1100 milligrams (mg) intravenous (IV) infusion every two weeks (14-day cycle) until unacceptable toxicity, documented disease progression or death. Participants also received 5 fluorouracil (5-FU) 400 milligrams per square meter (mg/m^2) as an IV bolus and then 5-FU 2400 mg/m^2 as a continuous IV infusion, irinotecan 180 milligrams per square meter (mg/m^2) IV infusion concurrently (using a y connector) with leucovorin 400 mg/m^2 (racemic form) or 200 mg/m^2 (L-isomer form) IV infusion (FOLFIRI) on Day 1 of 14-day continuous cycles.

    Reporting group title
    FOLFIRI + Cetuximab
    Reporting group description
    		 All participants received cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 IV infusion once a week until unacceptable toxicity, documented disease progression or death. Participants also received FOLFIRI on Day 1 of 14-day continuous cycles.

    Primary: Percentage of Participants With Disease Progression or Death

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    End point title
    		 Percentage of Participants With Disease Progression or Death [1]
    End point description
    Tumor assessments were performed according to modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline. In addition, the sum must also have shown an absolute increase of 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis of primary endpoints was performed on All randomized participants defined as all participants who were randomized. Participants were grouped according to the treatment to which they were randomized.
    End point type
    Primary
    End point timeframe
    Baseline and every 8 weeks until disease progression, unacceptable toxicity or death until 29 September 2014 (up to approximately 23 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint. The statistical analysis for progression-free survival is reported in next end point.
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    68
    66
    Units: percentage of participants
        number (not applicable)
    79.4
    75.8
    No statistical analyses for this end point

    Primary: Percentage of Participants With Disease Progression or Death in the HER3-Low Group

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    End point title
    		 Percentage of Participants With Disease Progression or Death in the HER3-Low Group [2]
    End point description
    HER3 is a protein encoded by the ERBB3 gene. HER3-low participants were identified based on the median ERBB3 expression. Tumor assessments were performed according to modified RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline. In addition, the sum must also have shown an absolute increase of 5 mm. The appearance of one or more new lesions was also considered progression. Analysis of primary endpoints was performed on All randomized participants defined as all participants who were randomized. Participants were grouped according to the treatment to which they were randomized within the HER3-low expressing group.
    End point type
    Primary
    End point timeframe
    Baseline and every 8 weeks until disease progression, unacceptable toxicity or death until 29 September 2014 (up to approximately 23 months)
    Notes
    [2] - 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 statistical analysis was planned for this endpoint.
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    27
    27
    Units: percentage of participants
        number (not applicable)
    77.78
    85.19
    No statistical analyses for this end point

    Primary: Duration of Progression Free Survival (PFS)

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    End point title
    		 Duration of Progression Free Survival (PFS)
    End point description
    PFS was defined as the time from randomization to documented disease progression assessed by the investigator or death, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline. In addition the sum must also have shown an absolute increase of 5 mm. The appearance of one or more new lesions was also considered progression. Analysis of primary endpoints was performed on all randomized participants and on those with HER3-low tumors.
    End point type
    Primary
    End point timeframe
    Baseline and every 8 weeks until disease progression, unacceptable toxicity or death until Study termination on 29 September 2014 (up to approximately 23 months)
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    68
    66
    Units: months
        median (confidence interval 90%)
    5.4 (3.8 to 7.5)
    5.6 (5.3 to 7.5)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Stratification variables included time between last 1L oxaliplatin-containing chemotherapy and disease progression less than or equal to 6 months versus greater than 6 months (<= 6 mo vs > 6 mo) and prior bevacizumab therapy (yes vs no). Hazard ratios were estimated by Cox regression.
    Comparison groups
    FOLFIRI+ MEHD7945A v FOLFIRI + Cetuximab
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.198
    Method
    		 Logrank
    Parameter type
    		 Log hazard ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.82

    Primary: Duration of PFS in HER3-Low Group

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    End point title
    		 Duration of PFS in HER3-Low Group [3]
    End point description
    HER3 is a protein encoded by the ERBB3 gene. HER3-low participants were identified based on the median ERBB3 expression. PFS was defined as the time from randomization to documented disease progression assessed by the investigator or death, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline. In addition the sum must also have shown an absolute increase of 5 mm. The appearance of one or more new lesions was also considered progression. Analysis of primary endpoints was performed on all randomized participants and on those with HER3-low tumors.
    End point type
    Primary
    End point timeframe
    Baseline and every 8 weeks until disease progression, unacceptable toxicity or death until Study termination on 29 September 2014 (up to approximately 23 months)
    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 statistical analysis was planned for this endpoint.
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    27
    27
    Units: months
        median (confidence interval 90%)
    3.9 (3.7 to 7.5)
    5.5 (3.9 to 5.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR])

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    End point title
    		 Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR])
    End point description
    Objective response is defined as a CR or PR, objective responses had to be confirmed ≥ 4 weeks after the initial response. Tumor assessments were performed according to modified RECIST v1.1. CR: Disappearance of all target lesions, and any pathological lymph nodes (whether target or non-target) must have shown a reduction in the short axis to less than (<)10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Analysis of secondary outcomes was performed on all randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline and every 8 weeks until Disease progression, Unacceptable Toxicity or Death until Study termination on 29 September 2014 (up to approximately 23 months)
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    68
    66
    Units: percentage of partticipants
        number (confidence interval 90%)
    16.2 (9.9 to 24.38)
    31.8 (22.41 to 42.23)
    No statistical analyses for this end point

    Secondary: Duration of Objective Response

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    End point title
    		 Duration of Objective Response
    End point description
    Duration of objective response was defined as the time from the first occurrence of a documented objective response (CR or PR) to documented disease progression or death, whichever occurred first. Analysis was performed on all randomized participants. Time to event was determined using Kaplan-Meier estimates. Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley.
    End point type
    Secondary
    End point timeframe
    Baseline and every 8 weeks until Disease progression, Unacceptable Toxicity or Death until Study termination on 29 September 2014 (up to approximately 23 months)
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    11
    21
    Units: months
        median (confidence interval 90%)
    7.1 (5.5 to 9.1)
    9 (5.6 to 11)
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Stratification variables include time between last 1L oxaliplatin-containing chemotherapy and disease progression (<= 6 months vs > 6 months and prior bevacizumab therapy (yes vs no). Hazard ratios were estimated by Cox regression.
    Comparison groups
    FOLFIRI+ MEHD7945A v FOLFIRI + Cetuximab
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2185
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.84
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 4.22

    Secondary: Percentage of Participants Who Died

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    End point title
    		 Percentage of Participants Who Died
    End point description
    Overall survival was defined as the time from randomization to death by any cause.
    End point type
    Secondary
    End point timeframe
    Baseline and every 8 weeks until Death (up to approximately 25 months)
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    68
    66
    Units: percentage of participants
        number (not applicable)
    50
    50
    No statistical analyses for this end point

    Secondary: Duration of Overall Survival

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    End point title
    		 Duration of Overall Survival
    End point description
    Overall survival was defined as the time from randomization to death by any cause. Time to event was estimated using Kaplan-Meier estimates. The number “99999” in data field signifies not estimated (NE) data, as the upper limit of 90% CI was not reached in the Kaplan-Meier analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and every 8 weeks until Death (up to approximately 25 months)
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    68
    66
    Units: months
        median (confidence interval 90%)
    14 (11 to 20.3)
    12.4 (10.2 to 99999)
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Stratification variables include time between last 1L oxaliplatin-containing chemotherapy and disease progression (<= 6 months vs > 6 months and prior bevacizumab therapy (yes vs no). Hazard ratios were estimated by Cox regression.
    Comparison groups
    FOLFIRI + Cetuximab v FOLFIRI+ MEHD7945A
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9009
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.46

    Secondary: Minimum (Cmin) and Maximum (Cmax) Serum Concentrations of MEHD7945A

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    End point title
    		 Minimum (Cmin) and Maximum (Cmax) Serum Concentrations of MEHD7945A [4]
    End point description
    Cmax was defined as the maximum or “peak” concentration of MEHD7945A observed after its administration (30 minutes post dose); Cmin was the minimum or “trough” concentration of MEHD7945A (pre dose).
    End point type
    Secondary
    End point timeframe
    Pre dose and 30 minutes post dose on Cycle 1 Day 1, Pre dose on Cycle 10 Day 1
    Notes
    [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: This endpoint was planned to be reported only in those participants who received MEHD7945A.
    End point values
    		 FOLFIRI+ MEHD7945A
    Number of subjects analysed
    66
    Units: micrograms per milliliter (µg/mL)
    arithmetic mean (standard deviation)
        Cycle 1 Cmin
    39.466 ( 43.66 )
        Cycle 1 Cmax
    299.028 ( 66.319 )
        Cycle 10 Cmin
    75.965 ( 42.619 )
    No statistical analyses for this end point

    Secondary: Percentage of participants with anti-MEHD7945A antibodies

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    End point title
    		 Percentage of participants with anti-MEHD7945A antibodies
    End point description
    Anti-therapeutic antibodies (ATAs) directed against MEHD7945A were analyzed in serum samples obtained at baseline, before dosing, and at multiple time points (Day 1 of Cycles 1, 4, 8, and at treatment completion) after dosing. Number (n) = number of evaluable participants for the specified category.
    End point type
    Secondary
    End point timeframe
    Baseline; Post Baseline (assessed at Day 1 of Cycles 1, 4 and 8 and at study termination on 29 September 2014 [up to approximately 23 months])
    End point values
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Number of subjects analysed
    66
    17
    Units: percentage of participants
    number (not applicable)
        Baseline (n=66,4)
    0
    0
        Post-baseline treatment induced ATA (n=59,17)
    0
    0
        Post-baseline treatment enhanced ATA (n=59,17)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were recorded from the date of randomization until 45 days after study termination (up to approximately 25 months).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    FOLFIRI+ MEHD7945A
    Reporting group description
    		 Participants received MEHD7945A 1100 mg IV infusion every two weeks (14-day cycle) until unacceptable toxicity, documented disease progression or death. Participants also received 5-FU 400 mg/m^2 as an IV bolus and then 5-FU 2400 mg/m^2 as a continuous IV infusion, irinotecan 180 mg/m^2 IV infusion concurrently (using a y connector) with leucovorin 400 mg/m^2 (racemic form) or 200 mg/m^2 (L-isomer form) IV infusion (FOLFIRI) on Day 1 of 14-day continuous cycles. AEs were reported for Safety Evaluable population which included all participants who were randomized and received any amount of study medication.

    Reporting group title
    FOLFIRI + Cetuximab
    Reporting group description
    		 All participants received cetuximab 400 mg/m^2 initial dose followed by 250 mg/m^2 IV infusion once a week until unacceptable toxicity, documented disease progression or death. Participants also received FOLFIRI on Day 1 of 14-day continuous cycles. AEs were reported for Safety Evaluable population which included all participants who were randomized and received any amount of study medication.

    Serious adverse events
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 67 (35.82%)
    23 / 63 (36.51%)
         number of deaths (all causes)
    34
    33
         number of deaths resulting from adverse events
    Vascular disorders
    Vena cava thrombosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 63 (6.35%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 63 (4.76%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsions
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Corneal perforation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 63 (6.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 67 (8.96%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    7 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 63 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal perforation
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric haematoma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmar- plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Obstructive uropathy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site cellulitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 63 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nail bed infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FOLFIRI+ MEHD7945A FOLFIRI + Cetuximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 67 (100.00%)
    63 / 63 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    43 / 67 (64.18%)
    37 / 63 (58.73%)
         occurrences all number
    64
    88
    Mucosal inflammation
         subjects affected / exposed
    26 / 67 (38.81%)
    23 / 63 (36.51%)
         occurrences all number
    49
    40
    Asthenia
         subjects affected / exposed
    10 / 67 (14.93%)
    9 / 63 (14.29%)
         occurrences all number
    18
    18
    Pyrexia
         subjects affected / exposed
    6 / 67 (8.96%)
    11 / 63 (17.46%)
         occurrences all number
    8
    15
    Oedema peripheral
         subjects affected / exposed
    5 / 67 (7.46%)
    6 / 63 (9.52%)
         occurrences all number
    5
    7
    Chest pain
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    13 / 67 (19.40%)
    8 / 63 (12.70%)
         occurrences all number
    16
    10
    Dyspnoea
         subjects affected / exposed
    8 / 67 (11.94%)
    5 / 63 (7.94%)
         occurrences all number
    8
    8
    Cough
         subjects affected / exposed
    2 / 67 (2.99%)
    12 / 63 (19.05%)
         occurrences all number
    2
    13
    Dysphonia
         subjects affected / exposed
    6 / 67 (8.96%)
    2 / 63 (3.17%)
         occurrences all number
    6
    2
    Oropharyngeal pain
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 63 (4.76%)
         occurrences all number
    4
    3
    Pulmonary embolism
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 63 (6.35%)
         occurrences all number
    3
    4
    Rhinorrhoea
         subjects affected / exposed
    5 / 67 (7.46%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 67 (5.97%)
    11 / 63 (17.46%)
         occurrences all number
    4
    12
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 67 (11.94%)
    5 / 63 (7.94%)
         occurrences all number
    11
    5
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 63 (6.35%)
         occurrences all number
    1
    4
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    11 / 67 (16.42%)
    6 / 63 (9.52%)
         occurrences all number
    15
    6
    Headache
         subjects affected / exposed
    10 / 67 (14.93%)
    6 / 63 (9.52%)
         occurrences all number
    10
    6
    Dizziness
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 63 (4.76%)
         occurrences all number
    8
    3
    Neuropathy peripheral
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 63 (6.35%)
         occurrences all number
    3
    6
    Paraesthesia
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 63 (6.35%)
         occurrences all number
    2
    6
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    17 / 67 (25.37%)
    21 / 63 (33.33%)
         occurrences all number
    27
    41
    Anaemia
         subjects affected / exposed
    9 / 67 (13.43%)
    11 / 63 (17.46%)
         occurrences all number
    14
    14
    Leukopenia
         subjects affected / exposed
    1 / 67 (1.49%)
    5 / 63 (7.94%)
         occurrences all number
    1
    9
    Thrombocytopenia
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 63 (6.35%)
         occurrences all number
    1
    5
    Eye disorders
    Vision blurred
         subjects affected / exposed
    5 / 67 (7.46%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    60 / 67 (89.55%)
    42 / 63 (66.67%)
         occurrences all number
    145
    107
    Nausea
         subjects affected / exposed
    33 / 67 (49.25%)
    32 / 63 (50.79%)
         occurrences all number
    49
    61
    Stomatitis
         subjects affected / exposed
    21 / 67 (31.34%)
    26 / 63 (41.27%)
         occurrences all number
    34
    44
    Vomiting
         subjects affected / exposed
    16 / 67 (23.88%)
    11 / 63 (17.46%)
         occurrences all number
    23
    27
    Abdominal pain
         subjects affected / exposed
    12 / 67 (17.91%)
    21 / 63 (33.33%)
         occurrences all number
    18
    26
    Constipation
         subjects affected / exposed
    6 / 67 (8.96%)
    16 / 63 (25.40%)
         occurrences all number
    6
    26
    Gastroesophageal reflux disease
         subjects affected / exposed
    10 / 67 (14.93%)
    6 / 63 (9.52%)
         occurrences all number
    11
    7
    Mouth ulceration
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 63 (6.35%)
         occurrences all number
    8
    8
    Oral pain
         subjects affected / exposed
    7 / 67 (10.45%)
    1 / 63 (1.59%)
         occurrences all number
    8
    4
    Abdominal pain upper
         subjects affected / exposed
    5 / 67 (7.46%)
    6 / 63 (9.52%)
         occurrences all number
    5
    6
    Dry mouth
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 63 (6.35%)
         occurrences all number
    6
    4
    Haemorrhoids
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 63 (6.35%)
         occurrences all number
    6
    4
    Rectal haemorrhage
         subjects affected / exposed
    3 / 67 (4.48%)
    5 / 63 (7.94%)
         occurrences all number
    3
    7
    Cheilitis
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 63 (1.59%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    26 / 67 (38.81%)
    32 / 63 (50.79%)
         occurrences all number
    48
    68
    Dermatitis acneiform
         subjects affected / exposed
    24 / 67 (35.82%)
    22 / 63 (34.92%)
         occurrences all number
    42
    57
    Alopecia
         subjects affected / exposed
    18 / 67 (26.87%)
    22 / 63 (34.92%)
         occurrences all number
    19
    24
    Dry skin
         subjects affected / exposed
    17 / 67 (25.37%)
    13 / 63 (20.63%)
         occurrences all number
    19
    19
    Skin fissures
         subjects affected / exposed
    10 / 67 (14.93%)
    12 / 63 (19.05%)
         occurrences all number
    16
    18
    Palmar- plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    12 / 67 (17.91%)
    13 / 63 (20.63%)
         occurrences all number
    13
    20
    Pruritus
         subjects affected / exposed
    6 / 67 (8.96%)
    7 / 63 (11.11%)
         occurrences all number
    9
    7
    Rash maculo-papular
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 63 (6.35%)
         occurrences all number
    6
    5
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 63 (6.35%)
         occurrences all number
    1
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 67 (11.94%)
    6 / 63 (9.52%)
         occurrences all number
    10
    7
    Arthralgia
         subjects affected / exposed
    6 / 67 (8.96%)
    3 / 63 (4.76%)
         occurrences all number
    9
    3
    Pain in extremity
         subjects affected / exposed
    2 / 67 (2.99%)
    6 / 63 (9.52%)
         occurrences all number
    2
    8
    Muscle spasms
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 63 (3.17%)
         occurrences all number
    5
    2
    Infections and infestations
    Paronychia
         subjects affected / exposed
    21 / 67 (31.34%)
    18 / 63 (28.57%)
         occurrences all number
    39
    34
    Folliculitis
         subjects affected / exposed
    1 / 67 (1.49%)
    8 / 63 (12.70%)
         occurrences all number
    1
    12
    Urinary tract infection
         subjects affected / exposed
    7 / 67 (10.45%)
    6 / 63 (9.52%)
         occurrences all number
    7
    6
    Conjunctivitis
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 63 (6.35%)
         occurrences all number
    7
    5
    Localised infection
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    0
    4
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    25 / 67 (37.31%)
    13 / 63 (20.63%)
         occurrences all number
    35
    21
    Decreased appetite
         subjects affected / exposed
    16 / 67 (23.88%)
    14 / 63 (22.22%)
         occurrences all number
    23
    23
    Hypomagnesaemia
         subjects affected / exposed
    12 / 67 (17.91%)
    23 / 63 (36.51%)
         occurrences all number
    12
    23
    Dehydration
         subjects affected / exposed
    9 / 67 (13.43%)
    4 / 63 (6.35%)
         occurrences all number
    10
    9
    Hypophosphataemia
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 63 (6.35%)
         occurrences all number
    7
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2012
    The protocol was updated to include two interim safety analyses by the internal monitoring committee (IMC) instead of one interim analysis. The duration of safety monitoring (including reporting of AEs and SAEs) was extended from 30 days to 45 days. Changes were made to Inclusion and Exclusion criteria.
    26 Apr 2013
    Incidence of ATA to MEHD7945A was added as a safety outcome measure. Electrocardiogram (ECG) was added as a safety assessment. The follow-up period for reporting pregnancy was updated to 45 days. Clarification was added to the dosage modification of 1) MEHD7945A, 2) cetuximab and 3) folinic acid

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated on 29 September 2014, following the primary analysis, which indicated that treatment with MEHD7945A FOLFIRI did not improve PFS compared with FOLFIRI cetuximab, by investigator assessment.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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