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Trial record 1 of 1 for:    NCT02610140
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Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

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ClinicalTrials.gov Identifier: NCT02610140
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : July 17, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
ImmunoGen and MorphoSys
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: Anetumab ravtansine (BAY94-9343)
Drug: Vinorelbine
Enrollment 248
Recruitment Details  
Pre-assignment Details Overall, 315 patients were screened; of these, 67 patients were screening failures.
Arm/Group Title Anetumab Ravtansine (Experimental) Vinorelbine (Active Comparator)
Hide Arm/Group Description Experimental Active comparator
Period Title: Randomization and Treatment Period
Started [1] 166 82
Participants Received Treatment 163 [2] 72 [2]
Completed 0 0
Not Completed 166 82
Reason Not Completed
Radiological progression             23             15
Progressive disease - radiological             54             23
Protocol Violation             1             0
Physician Decision             0             1
Lack of Efficacy             1             0
Death             7             1
Withdrawal by Subject             12             12
Adverse Event             44             13
Progressive disease - clinical             12             5
Ongoing but not completed             9             2
Not treated             3             10
[1]
Randomized
[2]
Safety analysis set
Period Title: Safety Follow-up
Started [1] 102 45
Completed 57 21
Not Completed 45 24
Reason Not Completed
Other             0             2
Lost to Follow-up             1             0
No follow-up             5             3
Death             12             2
Deterioration of general conditions             15             5
Withdrawal by Subject             12             12
[1]
Safety follow-up performed
Period Title: Active Follow-up
Started 48 26
Completed 0 0
Not Completed 48 26
Reason Not Completed
Progressive disease - radiological             30             22
Death             8             1
Withdrawal by Subject             4             0
Progressive disease - clinical             1             2
Deterioration of general conditions             1             0
Ongoing but not completed             4             1
Period Title: Long-term Follow-up
Started 123 66
Completed 0 0
Not Completed 123 66
Reason Not Completed
Death             86             44
Withdrawal by Subject             6             3
Lost to Follow-up             1             2
Ongoing but not completed             30             17
Arm/Group Title Anetumab Ravtansine (Experimental) Vinorelbine (Active Comparator) Total
Hide Arm/Group Description Experimental Active comparator Total of all reporting groups
Overall Number of Baseline Participants 166 82 248
Hide Baseline Analysis Population Description
Intent-to-treat set (ITT): all randomized participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 82 participants 248 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
66
  39.8%
37
  45.1%
103
  41.5%
>=65 years
100
  60.2%
45
  54.9%
145
  58.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 82 participants 248 participants
66.1  (8.1) 65.6  (8.8) 65.9  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 82 participants 248 participants
Female
44
  26.5%
20
  24.4%
64
  25.8%
Male
122
  73.5%
62
  75.6%
184
  74.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 82 participants 248 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.2%
1
   1.2%
3
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.8%
0
   0.0%
3
   1.2%
White
157
  94.6%
75
  91.5%
232
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   2.4%
6
   7.3%
10
   4.0%
1.Primary Outcome
Title Progression-free Survival (PFS), [95% CI]
Hide Description Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
Time Frame From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis (PFS) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(4.1 to 5.5)
4.5
(4.1 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments PFS anetumab ravtansine / vinorelbine
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.859125
Comments 1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.215
Confidence Interval (2-Sided) 95%
0.850 to 1,738
Estimation Comments Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.
2.Secondary Outcome
Title Overall Survival (OS), [95% CI]
Hide Description Overall survival (OS) was defined as time from randomization until death from any cause.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Median (95% Confidence Interval)
Unit of Measure: months
9.5
(8.3 to 12.3)
11.6
(8.6 to 13.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments OS anetumab ravtansine / vinorelbine
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655624
Comments 1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.072
Confidence Interval (2-Sided) 95%
0.763 to 1.506
Estimation Comments Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
Time Frame up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (ORR) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.4
(4.7 to 13.7)
6.1
(2.0 to 13.7)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (DCR) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.5
(66.1 to 80.0)
68.3
(57.1 to 78.1)
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (DOR) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Median (95% Confidence Interval)
Unit of Measure: months
7.4 [1] 
(6.0 to NA)
6.7
(3.0 to 10.3)
[1]
NA = value cannot be estimated due to censored data
6.Secondary Outcome
Title Durable Response Rate (DRR)
Hide Description A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (DRR) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.2
(3.8 to 12.3)
4.9
(1.3 to 12.0)
7.Secondary Outcome
Title Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
Hide Description Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma.
Time Frame up to approx. 30 months (data cut-off: 31-May-2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.5
(15.1 to 31.4)
17.9
(8.9 to 30.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments Anetumab ravtansine versus vinorelbine
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
Method of Estimation Estimation Parameter Difference (%) improvement rate symptoms
Estimated Value 4.65
Confidence Interval (2-Sided) 95%
-8.20 to 17.51
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to Worsening of Symptoms Characteristic of Mesothelioma
Hide Description Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS.
Time Frame up to approx. 30 months (data cut-off: 31-May-2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
value cannot be estimated due to censored data
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments Anetumab ravtansine versus vinorelbine
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313747
Comments [Not Specified]
Method Log Rank
Comments one-sided log-rank test stratified by time to progression (TTP) on first line treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.829
Confidence Interval (2-Sided) 95%
0.386 to 1.779
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to Worsening of Pain
Hide Description Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score.
Time Frame up to approx. 30 months (data cut-off: 31-May-2017)
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Median (95% Confidence Interval)
Unit of Measure: days
210 [1] 
(127 to NA)
NA [1] 
(85 to NA)
[1]
value cannot be estimated due to censored data
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments Anetumab ravtansine versus vinorelbine
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378916
Comments [Not Specified]
Method Log Rank
Comments one-sided log-rank test stratified by time to progression (TTP) on first line treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.924
Confidence Interval (2-Sided) 95%
0.557 to 1.533
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Confirmed Improvement of Pain
Hide Description Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.4
(30.9 to 50.5)
32.7
(19.9 to 47.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments 1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
Method of Estimation Estimation Parameter Difference (%) improvement rate of pain
Estimated Value 6.64
Confidence Interval (2-Sided) 95%
-9.40 to 22.68
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as all AEs starting or worsening within the treatment period.
Time Frame Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (TEAEs) was performed in the safety analysis set (SAF).
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 163 72
Measure Type: Number
Unit of Measure: Percentage of participants
Any TEAE 99.4 98.6
Any study drug-related TEAE 88.3 90.3
Treatment-emergent serious adverse events (TESAEs) 34.4 34.7
12.Secondary Outcome
Title Number of Deaths
Hide Description TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018.
Time Frame Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (TEAEs) was performed in the safety analysis set (SAF).
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 163 72
Measure Type: Number
Unit of Measure: Number of Deaths
10 1
13.Secondary Outcome
Title Overall Survival (OS) - Addendum
Hide Description Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019.
Time Frame Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set.
Arm/Group Title Anetumab Ravtansine Vinorelbine
Hide Arm/Group Description:
Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
Active comparator: 30 mg/m^2 once weekly
Overall Number of Participants Analyzed 166 82
Mean (95% Confidence Interval)
Unit of Measure: months
9.5
(8.3 to 12.3)
11.6
(8.6 to 13.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
0.1 to 39.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Anetumab Ravtansine, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.6
Confidence Interval (2-Sided) 95%
0.0 to 35.9
Estimation Comments [Not Specified]
Time Frame Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).
Adverse Event Reporting Description

An "updated" analysis of safety:

Treatment-emergent adverse events (TEAEs): defined as all AEs starting or worsening within the treatment period.

 
Arm/Group Title Anetumab Ravtansine (BAY94-9343) Vinorelbine
Hide Arm/Group Description Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour Active comparator: 30 mg/m^2 once weekly
All-Cause Mortality
Anetumab Ravtansine (BAY94-9343) Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   126/163 (77.30%)      55/72 (76.39%)    
Hide Serious Adverse Events
Anetumab Ravtansine (BAY94-9343) Vinorelbine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/163 (34.36%)      25/72 (34.72%)    
Blood and lymphatic system disorders     
Febrile neutropenia * 1  1/163 (0.61%)  1 1/72 (1.39%)  2
Neutropenia * 1  1/163 (0.61%)  3 3/72 (4.17%)  3
Cardiac disorders     
Atrial fibrillation * 1  3/163 (1.84%)  4 0/72 (0.00%)  0
Atrial flutter * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pericardial effusion * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  5/163 (3.07%)  6 1/72 (1.39%)  2
Ascites * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Constipation * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Diarrhoea * 1  1/163 (0.61%)  2 1/72 (1.39%)  1
Ileus paralytic * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Intestinal obstruction * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Pancreatitis acute * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Small intestinal obstruction * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Large intestinal obstruction * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
General disorders     
Chest pain * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Fatigue * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Pain * 1  1/163 (0.61%)  2 1/72 (1.39%)  2
Pyrexia * 1  3/163 (1.84%)  3 3/72 (4.17%)  3
General physical health deterioration * 1  3/163 (1.84%)  4 0/72 (0.00%)  0
Physical deconditioning * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Non-cardiac chest pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Immune system disorders     
Anaphylactic reaction * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Infections and infestations     
Abscess * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Bronchitis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pneumonia * 1  7/163 (4.29%)  9 5/72 (6.94%)  6
Sepsis * 1  2/163 (1.23%)  3 0/72 (0.00%)  0
Upper respiratory tract infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Urinary tract infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Viral infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Abscess limb * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Arthritis bacterial * 1  0/163 (0.00%)  0 1/72 (1.39%)  3
Enterocolitis infectious * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Lung infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Respiratory tract infection * 1  0/163 (0.00%)  0 2/72 (2.78%)  3
Post procedural sepsis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Vascular device infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Injury, poisoning and procedural complications     
Animal bite * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Clavicle fracture * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Infusion related reaction * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Investigations     
Electrocardiogram T wave inversion * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Neutrophil count decreased * 1  0/163 (0.00%)  0 1/72 (1.39%)  2
Metabolism and nutrition disorders     
Dehydration * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hypoalbuminaemia * 1  0/163 (0.00%)  0 1/72 (1.39%)  3
Decreased appetite * 1  1/163 (0.61%)  2 1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mesothelioma * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Cancer pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Tumour compression * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Nervous system disorders     
Facial paralysis * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Loss of consciousness * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Polyneuropathy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Somnolence * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Spinal cord compression * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Balance disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Brachial plexopathy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Psychiatric disorders     
Disorientation * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Mental status changes * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Renal and urinary disorders     
Renal failure * 1  1/163 (0.61%)  1 1/72 (1.39%)  2
Acute kidney injury * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Reproductive system and breast disorders     
Scrotal mass * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  7/163 (4.29%)  15 2/72 (2.78%)  2
Dyspnoea exertional * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pleural effusion * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Pleurisy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pneumonitis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pneumothorax * 1  1/163 (0.61%)  1 1/72 (1.39%)  2
Pulmonary embolism * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Respiratory failure * 1  0/163 (0.00%)  0 2/72 (2.78%)  2
Vascular disorders     
Hypotension * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Embolism * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anetumab Ravtansine (BAY94-9343) Vinorelbine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/163 (98.77%)      68/72 (94.44%)    
Blood and lymphatic system disorders     
Anaemia * 1  15/163 (9.20%)  25 20/72 (27.78%)  42
Febrile neutropenia * 1  0/163 (0.00%)  0 3/72 (4.17%)  3
Leukopenia * 1  2/163 (1.23%)  2 5/72 (6.94%)  12
Neutropenia * 1  3/163 (1.84%)  4 35/72 (48.61%)  80
Thrombocytopenia * 1  8/163 (4.91%)  13 0/72 (0.00%)  0
Thrombocytosis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Cardiac disorders     
Atrial fibrillation * 1  3/163 (1.84%)  3 1/72 (1.39%)  1
Atrial flutter * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Atrial tachycardia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Bundle branch block left * 1  0/163 (0.00%)  0 1/72 (1.39%)  2
Coronary artery occlusion * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Palpitations * 1  3/163 (1.84%)  3 1/72 (1.39%)  1
Pericardial effusion * 1  2/163 (1.23%)  2 1/72 (1.39%)  2
Sinus tachycardia * 1  5/163 (3.07%)  6 1/72 (1.39%)  1
Tachycardia * 1  2/163 (1.23%)  2 1/72 (1.39%)  1
Ear and labyrinth disorders     
Deafness * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Vertigo * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Hypoacusis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Excessive cerumen production * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Eye disorders     
Blepharitis * 1  5/163 (3.07%)  5 0/72 (0.00%)  0
Cataract * 1  9/163 (5.52%)  13 2/72 (2.78%)  2
Cataract cortical * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Cataract nuclear * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Conjunctival haemorrhage * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Corneal erosion * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Diplopia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Dry eye * 1  22/163 (13.50%)  26 0/72 (0.00%)  0
Eye discharge * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Eye irritation * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Eye pain * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Lacrimation decreased * 1  6/163 (3.68%)  7 0/72 (0.00%)  0
Lacrimation disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Lacrimation increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Ocular hypertension * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Photophobia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pinguecula * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Retinal haemorrhage * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Retinal tear * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Retinal vascular disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Vision blurred * 1  5/163 (3.07%)  6 0/72 (0.00%)  0
Visual acuity reduced * 1  6/163 (3.68%)  7 0/72 (0.00%)  0
Visual impairment * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Vitreous floaters * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Conjunctival hyperaemia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Eye pruritus * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Ocular discomfort * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Corneal disorder * 1  65/163 (39.88%)  156 0/72 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension * 1  4/163 (2.45%)  4 4/72 (5.56%)  4
Abdominal pain * 1  18/163 (11.04%)  27 10/72 (13.89%)  13
Abdominal pain lower * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Abdominal pain upper * 1  9/163 (5.52%)  14 5/72 (6.94%)  5
Aphthous ulcer * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Ascites * 1  3/163 (1.84%)  5 0/72 (0.00%)  0
Constipation * 1  29/163 (17.79%)  39 34/72 (47.22%)  51
Diarrhoea * 1  56/163 (34.36%)  91 15/72 (20.83%)  22
Dry mouth * 1  7/163 (4.29%)  8 0/72 (0.00%)  0
Dyspepsia * 1  13/163 (7.98%)  14 1/72 (1.39%)  1
Dysphagia * 1  2/163 (1.23%)  4 1/72 (1.39%)  1
Flatulence * 1  4/163 (2.45%)  4 1/72 (1.39%)  1
Gastrooesophageal reflux disease * 1  6/163 (3.68%)  7 1/72 (1.39%)  1
Gastrointestinal disorder * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Gastrointestinal pain * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Gingival bleeding * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Glossitis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Haemorrhoids * 1  1/163 (0.61%)  1 2/72 (2.78%)  2
Inguinal hernia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Lip oedema * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Mouth ulceration * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Nausea * 1  68/163 (41.72%)  130 24/72 (33.33%)  38
Oral pain * 1  0/163 (0.00%)  0 3/72 (4.17%)  3
Rectal haemorrhage * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Stomatitis * 1  2/163 (1.23%)  2 5/72 (6.94%)  6
Toothache * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Vomiting * 1  34/163 (20.86%)  62 5/72 (6.94%)  8
Aerophagia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Paraesthesia oral * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
General disorders     
Application site rash * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Asthenia * 1  32/163 (19.63%)  58 16/72 (22.22%)  37
Chest discomfort * 1  4/163 (2.45%)  6 3/72 (4.17%)  3
Chest pain * 1  27/163 (16.56%)  31 13/72 (18.06%)  21
Chills * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Fatigue * 1  60/163 (36.81%)  98 22/72 (30.56%)  47
Feeling cold * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Gait disturbance * 1  4/163 (2.45%)  4 0/72 (0.00%)  0
Hyperpyrexia * 1  1/163 (0.61%)  2 1/72 (1.39%)  1
Influenza like illness * 1  5/163 (3.07%)  8 5/72 (6.94%)  9
Injection site bruising * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Malaise * 1  8/163 (4.91%)  13 5/72 (6.94%)  5
Mass * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Mucosal inflammation * 1  2/163 (1.23%)  2 3/72 (4.17%)  3
Oedema * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Oedema peripheral * 1  11/163 (6.75%)  11 3/72 (4.17%)  4
Pain * 1  4/163 (2.45%)  5 1/72 (1.39%)  1
Pyrexia * 1  22/163 (13.50%)  25 12/72 (16.67%)  14
Peripheral swelling * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
General physical health deterioration * 1  3/163 (1.84%)  4 0/72 (0.00%)  0
Infusion site pain * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Infusion site swelling * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Inflammation * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Non-cardiac chest pain * 1  7/163 (4.29%)  10 3/72 (4.17%)  3
Infusion site extravasation * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Catheter site injury * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Hepatobiliary disorders     
Hepatic failure * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hepatocellular injury * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Jaundice cholestatic * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Immune system disorders     
Hypersensitivity * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Contrast media allergy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Infections and infestations     
Bronchitis * 1  4/163 (2.45%)  5 3/72 (4.17%)  4
Cellulitis * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Conjunctivitis * 1  3/163 (1.84%)  4 1/72 (1.39%)  1
Cystitis * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Ear infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Eye infection * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Eyelid infection * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Folliculitis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Gastroenteritis viral * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Gastrointestinal infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Genital candidiasis * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Herpes zoster * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Lower respiratory tract infection * 1  0/163 (0.00%)  0 2/72 (2.78%)  3
Nasopharyngitis * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Oral candidiasis * 1  5/163 (3.07%)  5 4/72 (5.56%)  4
Otitis media * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Paronychia * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Pneumonia * 1  2/163 (1.23%)  3 3/72 (4.17%)  3
Pyelonephritis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Sinusitis * 1  1/163 (0.61%)  1 2/72 (2.78%)  2
Tonsillitis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Upper respiratory tract infection * 1  5/163 (3.07%)  7 5/72 (6.94%)  8
Urinary tract infection * 1  7/163 (4.29%)  9 0/72 (0.00%)  0
Vaginal infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Rectal abscess * 1  1/163 (0.61%)  5 0/72 (0.00%)  0
Febrile infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Lung infection * 1  2/163 (1.23%)  2 1/72 (1.39%)  1
Oral fungal infection * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Bronchitis bacterial * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Penile infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Respiratory tract infection * 1  2/163 (1.23%)  2 1/72 (1.39%)  1
Lip infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Mucosal infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Peripheral nerve infection * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Infectious pleural effusion * 1  1/163 (0.61%)  3 0/72 (0.00%)  0
Candida infection * 1  1/163 (0.61%)  1 2/72 (2.78%)  2
Tongue fungal infection * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Injury, poisoning and procedural complications     
Accident * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Clavicle fracture * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Fall * 1  3/163 (1.84%)  3 2/72 (2.78%)  2
Ligament sprain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Scratch * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Muscle strain * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Infusion related reaction * 1  16/163 (9.82%)  22 4/72 (5.56%)  4
Stoma site pain * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Alanine aminotransferase increased * 1  20/163 (12.27%)  46 6/72 (8.33%)  10
Amylase increased * 1  5/163 (3.07%)  11 1/72 (1.39%)  1
Aspartate aminotransferase increased * 1  22/163 (13.50%)  43 4/72 (5.56%)  4
Bilirubin conjugated increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Blood albumin decreased * 1  1/163 (0.61%)  3 0/72 (0.00%)  0
Blood bilirubin increased * 1  3/163 (1.84%)  5 2/72 (2.78%)  2
Blood creatinine increased * 1  4/163 (2.45%)  5 1/72 (1.39%)  1
Blood lactic acid increased * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Blood pressure increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Blood urea increased * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
C-reactive protein increased * 1  3/163 (1.84%)  4 2/72 (2.78%)  2
Electrocardiogram QT prolonged * 1  5/163 (3.07%)  5 2/72 (2.78%)  3
Gamma-glutamyltransferase increased * 1  11/163 (6.75%)  24 3/72 (4.17%)  5
Glucose tolerance test abnormal * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Haemoglobin decreased * 1  2/163 (1.23%)  2 3/72 (4.17%)  5
Lipase increased * 1  7/163 (4.29%)  17 1/72 (1.39%)  1
Lymphocyte count decreased * 1  1/163 (0.61%)  1 2/72 (2.78%)  5
Neutrophil count decreased * 1  3/163 (1.84%)  5 17/72 (23.61%)  41
Platelet count decreased * 1  4/163 (2.45%)  11 0/72 (0.00%)  0
Weight decreased * 1  17/163 (10.43%)  23 8/72 (11.11%)  12
White blood cell count decreased * 1  2/163 (1.23%)  3 9/72 (12.50%)  25
White blood cell count increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Blood phosphorus decreased * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Blood phosphorus increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hypophonesis * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Platelet count increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Transaminases increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Blood alkaline phosphatase increased * 1  4/163 (2.45%)  4 0/72 (0.00%)  0
Waist circumference increased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Blood creatine phosphokinase decreased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Klebsiella test positive * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Tear break up time decreased * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Folate deficiency * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hyperglycaemia * 1  2/163 (1.23%)  3 1/72 (1.39%)  2
Hyperkalaemia * 1  2/163 (1.23%)  3 1/72 (1.39%)  1
Hypertriglyceridaemia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hyperuricaemia * 1  2/163 (1.23%)  3 1/72 (1.39%)  1
Hypoalbuminaemia * 1  1/163 (0.61%)  1 4/72 (5.56%)  5
Hypocalcaemia * 1  1/163 (0.61%)  1 2/72 (2.78%)  6
Hypokalaemia * 1  7/163 (4.29%)  8 2/72 (2.78%)  9
Hypomagnesaemia * 1  1/163 (0.61%)  1 2/72 (2.78%)  2
Hyponatraemia * 1  3/163 (1.84%)  5 2/72 (2.78%)  2
Hypophosphataemia * 1  1/163 (0.61%)  1 3/72 (4.17%)  5
Decreased appetite * 1  58/163 (35.58%)  75 17/72 (23.61%)  24
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  19/163 (11.66%)  29 3/72 (4.17%)  3
Back pain * 1  11/163 (6.75%)  13 9/72 (12.50%)  10
Bone pain * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Coccydynia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Flank pain * 1  1/163 (0.61%)  1 2/72 (2.78%)  3
Joint swelling * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Muscle discomfort * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Muscle spasms * 1  8/163 (4.91%)  8 3/72 (4.17%)  3
Muscular weakness * 1  6/163 (3.68%)  7 2/72 (2.78%)  2
Musculoskeletal pain * 1  10/163 (6.13%)  13 3/72 (4.17%)  3
Myalgia * 1  22/163 (13.50%)  34 5/72 (6.94%)  7
Myopathy * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Neck pain * 1  3/163 (1.84%)  3 0/72 (0.00%)  0
Pain in extremity * 1  10/163 (6.13%)  11 4/72 (5.56%)  5
Pain in jaw * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Rotator cuff syndrome * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Musculoskeletal chest pain * 1  9/163 (5.52%)  13 2/72 (2.78%)  3
Musculoskeletal stiffness * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Musculoskeletal discomfort * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Muscle contracture * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Tendon pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Spinal pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm skin * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Tumour pain * 1  2/163 (1.23%)  2 3/72 (4.17%)  3
Cancer pain * 1  5/163 (3.07%)  7 1/72 (1.39%)  1
Nervous system disorders     
Ageusia * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Asterixis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Burning sensation * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Dizziness * 1  6/163 (3.68%)  6 6/72 (8.33%)  6
Dizziness postural * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Dysaesthesia * 1  5/163 (3.07%)  11 0/72 (0.00%)  0
Dysarthria * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Dysgeusia * 1  7/163 (4.29%)  9 1/72 (1.39%)  1
Dyskinesia * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Headache * 1  15/163 (9.20%)  17 5/72 (6.94%)  8
Hypoaesthesia * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Lethargy * 1  4/163 (2.45%)  9 5/72 (6.94%)  12
Neuralgia * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Neuropathy peripheral * 1  27/163 (16.56%)  52 5/72 (6.94%)  6
Neurotoxicity * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Paraesthesia * 1  14/163 (8.59%)  44 5/72 (6.94%)  7
Peripheral motor neuropathy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Peripheral sensory neuropathy * 1  20/163 (12.27%)  44 0/72 (0.00%)  0
Polyneuropathy * 1  2/163 (1.23%)  8 0/72 (0.00%)  0
Sciatica * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Somnolence * 1  3/163 (1.84%)  7 0/72 (0.00%)  0
Syncope * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Tremor * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Balance disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Restless legs syndrome * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Brachial plexopathy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Taste disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Product Issues     
Device malfunction * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Device occlusion * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Psychiatric disorders     
Agitation * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Anxiety * 1  5/163 (3.07%)  9 3/72 (4.17%)  3
Confusional state * 1  4/163 (2.45%)  4 0/72 (0.00%)  0
Depressed mood * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Depression * 1  2/163 (1.23%)  2 1/72 (1.39%)  1
Enuresis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Insomnia * 1  11/163 (6.75%)  13 10/72 (13.89%)  10
Sleep disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Renal and urinary disorders     
Dysuria * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Haematuria * 1  2/163 (1.23%)  2 1/72 (1.39%)  1
Nocturia * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Proteinuria * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Renal failure * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Urinary retention * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Bladder trabeculation * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Urinary tract pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Acute kidney injury * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Breast pain * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Scrotal mass * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Penile oedema * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  22/163 (13.50%)  30 11/72 (15.28%)  15
Dysphonia * 1  2/163 (1.23%)  2 3/72 (4.17%)  3
Dyspnoea * 1  30/163 (18.40%)  44 20/72 (27.78%)  26
Dyspnoea exertional * 1  3/163 (1.84%)  4 0/72 (0.00%)  0
Epistaxis * 1  9/163 (5.52%)  12 1/72 (1.39%)  1
Haemoptysis * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Hiccups * 1  0/163 (0.00%)  0 1/72 (1.39%)  2
Hypoxia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Nasal congestion * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Nasal dryness * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Painful respiration * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pleural effusion * 1  3/163 (1.84%)  5 1/72 (1.39%)  1
Pleuritic pain * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Pneumonitis * 1  0/163 (0.00%)  0 1/72 (1.39%)  4
Pneumothorax * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Productive cough * 1  3/163 (1.84%)  3 1/72 (1.39%)  1
Pulmonary embolism * 1  1/163 (0.61%)  2 0/72 (0.00%)  0
Rhinorrhoea * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Diaphragmalgia * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Increased viscosity of bronchial secretion * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Increased upper airway secretion * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Oropharyngeal pain * 1  4/163 (2.45%)  4 3/72 (4.17%)  3
Upper-airway cough syndrome * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia * 1  3/163 (1.84%)  3 2/72 (2.78%)  2
Dermatitis * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Dermatitis acneiform * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Dry skin * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Eczema * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Erythema * 1  1/163 (0.61%)  4 1/72 (1.39%)  1
Erythema multiforme * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Hyperhidrosis * 1  5/163 (3.07%)  5 1/72 (1.39%)  1
Hyperkeratosis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Ingrowing nail * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Nail disorder * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Night sweats * 1  7/163 (4.29%)  9 2/72 (2.78%)  2
Palmar-plantar erythrodysaesthesia syndrome * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Photosensitivity reaction * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Pruritus * 1  3/163 (1.84%)  5 0/72 (0.00%)  0
Psoriasis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Rash * 1  9/163 (5.52%)  12 3/72 (4.17%)  3
Rash macular * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Rash maculo-papular * 1  2/163 (1.23%)  4 0/72 (0.00%)  0
Rash papular * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Rash pruritic * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Skin hypertrophy * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Skin irritation * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Pruritus generalised * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Surgical and medical procedures     
Dermabrasion * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Inguinal hernia repair * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Vascular disorders     
Flushing * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Haematoma * 1  1/163 (0.61%)  1 1/72 (1.39%)  1
Hypertension * 1  9/163 (5.52%)  13 2/72 (2.78%)  5
Hypotension * 1  1/163 (0.61%)  2 1/72 (1.39%)  1
Jugular vein thrombosis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Peripheral coldness * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Phlebitis * 1  0/163 (0.00%)  0 6/72 (8.33%)  9
Raynaud's phenomenon * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Vascular pain * 1  0/163 (0.00%)  0 1/72 (1.39%)  1
Deep vein thrombosis * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Superior vena cava occlusion * 1  2/163 (1.23%)  2 0/72 (0.00%)  0
Hot flush * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
Embolism * 1  1/163 (0.61%)  1 0/72 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreed point of publication is 12-18 months after database lock at the earliest. Bayer will have 30-45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). No publication of single center data should be done prior of publication if multi-center data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer AG
Phone: (+) 1-888-8422937
EMail: clinical-trials-contact@bayer.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02610140    
Other Study ID Numbers: 15743
2012-003650-88 ( EudraCT Number )
First Submitted: November 9, 2015
First Posted: November 20, 2015
Results First Submitted: May 22, 2020
Results First Posted: July 17, 2020
Last Update Posted: November 4, 2020