Trial Outcomes & Findings for Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma (NCT NCT03126630)
NCT ID: NCT03126630
Last Updated: 2025-10-16
Results Overview
Will be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Phase 2 Group I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.
\>
\>
\>
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\> Laboratory Biomarker Analysis: Correlative studies
\>
\>
\>
\>
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\> Pembrolizumab: Given IV
\>
\>
\>
\>
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\> Pharmacological Study: Correlative studies
|
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.
\>
\>
\>
\>
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\> Anetumab Ravtansine: Given IV
\>
\>
\>
\>
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\>
\>
\>
\>
\> Pembrolizumab: Given IV
\>
\>
\>
\>
\>
\> Pharmacological Study: Correlative studies
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Phase 1 Cohort Dose Level 1
Anetumab Ravtansine Dose 6.5 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
13
|
|
Overall Study
COMPLETED
|
18
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Phase 2 Group I (Pembrolizumab)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 Participants
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Anetumab Ravtansine: Given IV\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Phase 1 Cohort DLT 1: Anetumab Ravtansine & MK-3475
n=13 Participants
Anetumab ravtansine: Day 1 of each cycle for up to 12 months\> MK-3475 (pembrolizumab): Day 1 of each cycle for up to 24 months
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.0 years
n=5 Participants
|
67.5 years
n=7 Participants
|
72 years
n=5 Participants
|
68.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Histologic Grade
Borderline malignancy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Histologic Grade
Grade cannot be assessed
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Histologic Grade
Poorly Differentiated
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Histologic Grade
Well Differentiated
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Histologic Grade
Missing
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Disease Stage
Stage IA
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Disease Stage
Stage IB
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Disease Stage
Stage II
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Disease Stage
Stage III
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Disease Stage
Stage IIIB
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Disease Stage
Stage IV
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Disease Stage
Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Weight
|
77.2 kg
n=5 Participants
|
80.1 kg
n=7 Participants
|
85.0 kg
n=5 Participants
|
80.4 kg
n=4 Participants
|
|
Height
|
168.4 cm
n=5 Participants
|
173.1 cm
n=7 Participants
|
167.3 cm
n=5 Participants
|
169.2 cm
n=4 Participants
|
|
BSA
|
1.9 m^2
n=5 Participants
|
1.9 m^2
n=7 Participants
|
1.9 m^2
n=5 Participants
|
1.9 m^2
n=4 Participants
|
|
ECOG Performance Score
0
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
ECOG Performance Score
1
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsWill be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 Participants
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Anetumab Ravtansine: Given IV\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase 2 Confirmed Tumor Response Rate (Phase II)
NE
|
2 Participants
|
4 Participants
|
|
Phase 2 Confirmed Tumor Response Rate (Phase II)
PD (Preliminary)
|
6 Participants
|
2 Participants
|
|
Phase 2 Confirmed Tumor Response Rate (Phase II)
PD (Confirmed)
|
3 Participants
|
1 Participants
|
|
Phase 2 Confirmed Tumor Response Rate (Phase II)
SD
|
5 Participants
|
9 Participants
|
|
Phase 2 Confirmed Tumor Response Rate (Phase II)
PR (Confirmed)
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsAll patients that have received any amount of the combination anetumab ravtansine and pembrolizumab will be evaluable for toxicity. Please note this is different from the definition of evaluable for dose-limiting toxicity (DLT) where patients who cannot complete the planned dose due to reasons other than toxicity will be replaced.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Group II (Anetumab Ravtansine, Pembrolizumab)
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Anetumab Ravtansine: Given IV\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab
|
6.5 mg/kg IV
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data were not collected and the outcome cannot be reported.
Will be defined as evaluable patients who achieved noted to be a partial response or complete response based Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test. This calculation will start with the date of start of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of treatment to death due to any cause, assessed up to 2 yearsWill be estimated using the method of Kaplan-Meier. The comparison of overall survival in event of death between two treatment arms will be based on the log-rank test.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 Participants
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Anetumab Ravtansine: Given IV\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase 2 Overall Survival
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 yearsWill be estimated using the method of Kaplan-Meier. The comparison of progression-free survival between two treatment arms will be based on the log-rank test. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 Participants
Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Anetumab Ravtansine: Given IV\>
\>\>
\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>
\>\>
\>
\>\> Pembrolizumab: Given IV\>
\>\>
\>
\>\> Pharmacological Study: Correlative studies
|
|---|---|---|
|
Phase 2 Progression Free Survival
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 3 of courses 1 and 8Will be largely descriptive. Changes over time will be plotted and assessed for each patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsRelative changes in biomarker levels will be compared by best overall response groups using the non-parametric Wilcoxon rank-sum test. Also, the associations between changes in megakaryocyte potentiating factor levels and ordered response categories (i.e. complete response-partial response-stable disease-progressive disease) will be assessed with the Jonckheere-Terpstra test for trend.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsThe mean equivalent soluble fluorophore and antibody bound to cell (ABC) will be determined for each specimen. Linear regression will be used to explore the linear relationship between the continuous values of these mononuclear phagocyte system-FcgammaRs probes and anetumab ravtansine levels. The concentrations of CCL2 and CCL5 will be determined for each specimen. Linear regression will be used to explore the linear relationship between the continuous values of these chemokines and anetumab ravtansine levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsTo explore the symptomatic adverse events (AE) for tolerability of each treatment group using Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
Outcome data not reported
Adverse Events
Phase 2 Group I (Pembrolizumab)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 1 deaths
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 2 deaths
Phase 1 Cohort DLT 1
Serious events: 1 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 2 Group I (Pembrolizumab)
n=17 participants at risk
Pharmacological Study: Correlative studies
|
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 participants at risk
Pharmacological Study: Correlative studies
|
Phase 1 Cohort DLT 1
n=13 participants at risk
Anetumab Ravtansine Dose 6.5 mg/kg
|
|---|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Phase 2 Group I (Pembrolizumab)
n=17 participants at risk
Pharmacological Study: Correlative studies
|
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
n=18 participants at risk
Pharmacological Study: Correlative studies
|
Phase 1 Cohort DLT 1
n=13 participants at risk
Anetumab Ravtansine Dose 6.5 mg/kg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
41.2%
7/17 • Number of events 42 • Up to 2 years
|
38.9%
7/18 • Number of events 32 • Up to 2 years
|
53.8%
7/13 • Number of events 54 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
11.8%
2/17 • Number of events 9 • Up to 2 years
|
22.2%
4/18 • Number of events 24 • Up to 2 years
|
7.7%
1/13 • Number of events 12 • Up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Cardiac disorders
Heart failure
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
33.3%
6/18 • Number of events 17 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 10 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
15.4%
2/13 • Number of events 6 • Up to 2 years
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
3/17 • Number of events 11 • Up to 2 years
|
16.7%
3/18 • Number of events 14 • Up to 2 years
|
23.1%
3/13 • Number of events 32 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 8 • Up to 2 years
|
15.4%
2/13 • Number of events 3 • Up to 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 12 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 9 • Up to 2 years
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 5 • Up to 2 years
|
22.2%
4/18 • Number of events 28 • Up to 2 years
|
15.4%
2/13 • Number of events 18 • Up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
11.8%
2/17 • Number of events 4 • Up to 2 years
|
33.3%
6/18 • Number of events 73 • Up to 2 years
|
23.1%
3/13 • Number of events 20 • Up to 2 years
|
|
Eye disorders
Eye pain
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Eye disorders
Keratitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
11.1%
2/18 • Number of events 11 • Up to 2 years
|
23.1%
3/13 • Number of events 20 • Up to 2 years
|
|
Eye disorders
Uveitis
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
16.7%
3/18 • Number of events 11 • Up to 2 years
|
30.8%
4/13 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 6 • Up to 2 years
|
27.8%
5/18 • Number of events 12 • Up to 2 years
|
46.2%
6/13 • Number of events 17 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Number of events 8 • Up to 2 years
|
61.1%
11/18 • Number of events 38 • Up to 2 years
|
53.8%
7/13 • Number of events 26 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
11.1%
2/18 • Number of events 8 • Up to 2 years
|
23.1%
3/13 • Number of events 32 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
5.6%
1/18 • Number of events 6 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 7 • Up to 2 years
|
15.4%
2/13 • Number of events 5 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
15.4%
2/13 • Number of events 11 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 9 • Up to 2 years
|
23.1%
3/13 • Number of events 16 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 18 • Up to 2 years
|
72.2%
13/18 • Number of events 62 • Up to 2 years
|
46.2%
6/13 • Number of events 19 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
3/17 • Number of events 5 • Up to 2 years
|
22.2%
4/18 • Number of events 7 • Up to 2 years
|
23.1%
3/13 • Number of events 5 • Up to 2 years
|
|
General disorders
Chills
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema limbs
|
0.00%
0/17 • Up to 2 years
|
27.8%
5/18 • Number of events 19 • Up to 2 years
|
15.4%
2/13 • Number of events 5 • Up to 2 years
|
|
General disorders
Fatigue
|
47.1%
8/17 • Number of events 58 • Up to 2 years
|
66.7%
12/18 • Number of events 81 • Up to 2 years
|
69.2%
9/13 • Number of events 48 • Up to 2 years
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
16.7%
3/18 • Number of events 7 • Up to 2 years
|
15.4%
2/13 • Number of events 12 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
General disorders
Gait disturbance
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
17.6%
3/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
General disorders
Malaise
|
5.9%
1/17 • Number of events 6 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 4 • Up to 2 years
|
16.7%
3/18 • Number of events 23 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
General disorders
Pain
|
23.5%
4/17 • Number of events 7 • Up to 2 years
|
16.7%
3/18 • Number of events 10 • Up to 2 years
|
15.4%
2/13 • Number of events 6 • Up to 2 years
|
|
Immune system disorders
Allergic reaction
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 9 • Up to 2 years
|
7.7%
1/13 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
11.8%
2/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • Number of events 3 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 8 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 6 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
2/17 • Number of events 3 • Up to 2 years
|
11.1%
2/18 • Number of events 4 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
23.1%
3/13 • Number of events 3 • Up to 2 years
|
|
Investigations
Activated partial throm time prolonged
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
38.9%
7/18 • Number of events 35 • Up to 2 years
|
53.8%
7/13 • Number of events 26 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
23.5%
4/17 • Number of events 14 • Up to 2 years
|
50.0%
9/18 • Number of events 22 • Up to 2 years
|
53.8%
7/13 • Number of events 36 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
23.5%
4/17 • Number of events 5 • Up to 2 years
|
61.1%
11/18 • Number of events 65 • Up to 2 years
|
61.5%
8/13 • Number of events 32 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Investigations
Cardiac troponin T increased
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Investigations
Creatinine increased
|
29.4%
5/17 • Number of events 19 • Up to 2 years
|
22.2%
4/18 • Number of events 6 • Up to 2 years
|
15.4%
2/13 • Number of events 10 • Up to 2 years
|
|
Investigations
ECG QT corrected interval prolonged
|
5.9%
1/17 • Number of events 14 • Up to 2 years
|
16.7%
3/18 • Number of events 5 • Up to 2 years
|
7.7%
1/13 • Number of events 3 • Up to 2 years
|
|
Investigations
Investigations - Other, specify
|
23.5%
4/17 • Number of events 14 • Up to 2 years
|
38.9%
7/18 • Number of events 39 • Up to 2 years
|
38.5%
5/13 • Number of events 42 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
35.3%
6/17 • Number of events 32 • Up to 2 years
|
22.2%
4/18 • Number of events 18 • Up to 2 years
|
46.2%
6/13 • Number of events 79 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 10 • Up to 2 years
|
15.4%
2/13 • Number of events 3 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
22.2%
4/18 • Number of events 23 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Investigations
Weight loss
|
17.6%
3/17 • Number of events 6 • Up to 2 years
|
27.8%
5/18 • Number of events 17 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
16.7%
3/18 • Number of events 10 • Up to 2 years
|
15.4%
2/13 • Number of events 11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • Number of events 7 • Up to 2 years
|
27.8%
5/18 • Number of events 21 • Up to 2 years
|
53.8%
7/13 • Number of events 17 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 4 • Up to 2 years
|
11.1%
2/18 • Number of events 5 • Up to 2 years
|
15.4%
2/13 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
7.7%
1/13 • Number of events 7 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.1%
8/17 • Number of events 46 • Up to 2 years
|
11.1%
2/18 • Number of events 5 • Up to 2 years
|
30.8%
4/13 • Number of events 8 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.5%
4/17 • Number of events 7 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
15.4%
2/13 • Number of events 7 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
41.2%
7/17 • Number of events 23 • Up to 2 years
|
50.0%
9/18 • Number of events 32 • Up to 2 years
|
38.5%
5/13 • Number of events 14 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
2/17 • Number of events 5 • Up to 2 years
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
15.4%
2/13 • Number of events 11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.8%
2/17 • Number of events 4 • Up to 2 years
|
11.1%
2/18 • Number of events 2 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
3/17 • Number of events 6 • Up to 2 years
|
44.4%
8/18 • Number of events 21 • Up to 2 years
|
23.1%
3/13 • Number of events 5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
2/17 • Number of events 3 • Up to 2 years
|
22.2%
4/18 • Number of events 4 • Up to 2 years
|
23.1%
3/13 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Number of events 6 • Up to 2 years
|
27.8%
5/18 • Number of events 26 • Up to 2 years
|
38.5%
5/13 • Number of events 23 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
15.4%
2/13 • Number of events 24 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • Number of events 7 • Up to 2 years
|
11.1%
2/18 • Number of events 10 • Up to 2 years
|
30.8%
4/13 • Number of events 22 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
17.6%
3/17 • Number of events 15 • Up to 2 years
|
5.6%
1/18 • Number of events 20 • Up to 2 years
|
23.1%
3/13 • Number of events 9 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/17 • Up to 2 years
|
27.8%
5/18 • Number of events 14 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
1/17 • Number of events 14 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
11.8%
2/17 • Number of events 5 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
23.1%
3/13 • Number of events 5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
11.1%
2/18 • Number of events 15 • Up to 2 years
|
38.5%
5/13 • Number of events 9 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 5 • Up to 2 years
|
15.4%
2/13 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 6 • Up to 2 years
|
7.7%
1/13 • Number of events 3 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
27.8%
5/18 • Number of events 18 • Up to 2 years
|
15.4%
2/13 • Number of events 7 • Up to 2 years
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • Number of events 6 • Up to 2 years
|
22.2%
4/18 • Number of events 15 • Up to 2 years
|
23.1%
3/13 • Number of events 9 • Up to 2 years
|
|
Nervous system disorders
Hypersomnia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
30.8%
4/13 • Number of events 15 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
11.8%
2/17 • Number of events 16 • Up to 2 years
|
11.1%
2/18 • Number of events 21 • Up to 2 years
|
7.7%
1/13 • Number of events 9 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/17 • Up to 2 years
|
16.7%
3/18 • Number of events 14 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
50.0%
9/18 • Number of events 72 • Up to 2 years
|
30.8%
4/13 • Number of events 48 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Transient ischemic attacks
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 14 • Up to 2 years
|
16.7%
3/18 • Number of events 17 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 4 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
11.1%
2/18 • Number of events 18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Psychiatric disorders
Irritability
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.4%
5/17 • Number of events 17 • Up to 2 years
|
11.1%
2/18 • Number of events 7 • Up to 2 years
|
46.2%
6/13 • Number of events 10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.2%
7/17 • Number of events 41 • Up to 2 years
|
38.9%
7/18 • Number of events 17 • Up to 2 years
|
46.2%
6/13 • Number of events 19 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 4 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 15 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
11.1%
2/18 • Number of events 6 • Up to 2 years
|
7.7%
1/13 • Number of events 6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
5.6%
1/18 • Number of events 4 • Up to 2 years
|
15.4%
2/13 • Number of events 12 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
11.1%
2/18 • Number of events 12 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/17 • Up to 2 years
|
11.1%
2/18 • Number of events 5 • Up to 2 years
|
7.7%
1/13 • Number of events 3 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
15.4%
2/13 • Number of events 9 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.9%
1/17 • Number of events 7 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 14 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
15.4%
2/13 • Number of events 10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
22.2%
4/18 • Number of events 11 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 4 • Up to 2 years
|
22.2%
4/18 • Number of events 17 • Up to 2 years
|
15.4%
2/13 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
1/17 • Number of events 5 • Up to 2 years
|
11.1%
2/18 • Number of events 3 • Up to 2 years
|
23.1%
3/13 • Number of events 9 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
22.2%
4/18 • Number of events 9 • Up to 2 years
|
23.1%
3/13 • Number of events 18 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
5.6%
1/18 • Number of events 3 • Up to 2 years
|
7.7%
1/13 • Number of events 11 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
16.7%
3/18 • Number of events 25 • Up to 2 years
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
17.6%
3/17 • Number of events 7 • Up to 2 years
|
5.6%
1/18 • Number of events 2 • Up to 2 years
|
7.7%
1/13 • Number of events 4 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/17 • Up to 2 years
|
5.6%
1/18 • Number of events 1 • Up to 2 years
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/17 • Up to 2 years
|
0.00%
0/18 • Up to 2 years
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60