Trial Outcomes & Findings for A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC (NCT NCT02387216)
NCT ID: NCT02387216
Last Updated: 2021-10-12
Results Overview
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Results posted on
2021-10-12
Participant Flow
87 multi-national sites
One patient was inappropriately enrolled into the sherloc study hence why 152 and not 153
Participant milestones
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
49
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
100
|
47
|
Reasons for withdrawal
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Overall Study
Progressive disease
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Sponsor Decision
|
28
|
12
|
|
Overall Study
Death
|
60
|
23
|
|
Overall Study
Other
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Baseline characteristics by cohort
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=103 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=49 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 7.28 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
28 participants
n=5 Participants
|
10 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
15 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Metastatic burden (TNM Stage at Initial Diagnosis)
Stage IIA
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Metastatic burden (TNM Stage at Initial Diagnosis)
Stage IIB
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Metastatic burden (TNM Stage at Initial Diagnosis)
Stage IIIA
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Metastatic burden (TNM Stage at Initial Diagnosis)
Stage IIIB
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Metastatic burden (TNM Stage at Initial Diagnosis)
Stage IV
|
77 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Heregulin positive status and staining in archival tissue
|
103 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)Population: The Modified Intent-to-Treat (mITT) Population consisted of all randomized patients who received at least 1 dose of assigned therapy
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=71 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=38 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Progression Free Survival
|
3.4 months
Interval 1.9 to 5.7
|
4.1 months
Interval 2.7 to 6.3
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)Population: Modified Intent-to-Treat (ITT) population
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=71 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=38 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Overall Survival
|
7.7 months
Interval 3.6 to 10.4
|
8.4 months
Interval 5.8 to 14.7
|
SECONDARY outcome
Timeframe: Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)Population: Modified Intent-to-Treat (ITT) population
Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=71 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=38 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Objective Response Rate
Objective Response
|
14 Participants
|
2 Participants
|
|
Objective Response Rate
Partial Response (PR)
|
14 Participants
|
2 Participants
|
|
Objective Response Rate
Stable Disease (SD)
|
39 Participants
|
26 Participants
|
|
Objective Response Rate
Progressive Disease
|
12 Participants
|
5 Participants
|
|
Objective Response Rate
Not Evaluable
|
1 Participants
|
1 Participants
|
|
Objective Response Rate
No Evaluation
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)Population: Modified Intent-to-Treat Population
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=71 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=38 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Time to Progression
|
3.0 months
Interval 2.8 to 5.2
|
NA months
Due to an insufficient number of participants with event
|
SECONDARY outcome
Timeframe: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 monthsPopulation: Safety Population
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=103 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=49 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Patients with any TEAE-Serious Adverse event
|
40 participants
|
15 participants
|
|
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Patients with any NCI-CTCAE Grade 3 or Higher
|
76 participants
|
31 participants
|
|
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Patients with any TEAE-Related
|
99 participants
|
45 participants
|
SECONDARY outcome
Timeframe: The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment through concentrations of MM-121Population: The PK data were not collected for this abbreviated report. There was no pharmacokinetic data feasible for the analysis, and as such, no related analyses were performed. Hence, data could not be reported in the data table.
Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 monthsPopulation: Safety Population
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Outcome measures
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=103 Participants
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=49 Participants
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
TEAE-Related
|
96.1 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
TEAE-Serious Adverse event
|
38.8 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
NCI-CTCAE Grade 3 or Higher
|
73.8 percentage of participants
|
63.3 percentage of participants
|
Adverse Events
Arm A (Experimental): MM-121 in Combination With Docetaxel
Serious events: 40 serious events
Other events: 103 other events
Deaths: 64 deaths
Arm B (Comparator): Docetaxel Alone
Serious events: 15 serious events
Other events: 47 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=103 participants at risk
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=49 participants at risk
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Lipase increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Atrial flutter
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Cardio pulmonary failure
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Tachycardia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Colitis
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Pyrexia
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Chest pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Fatigue
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Mucosal inflammation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
General physical health deterioration
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Pneumonia
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Sepsis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Appendicitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Bronchitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Clostridium difficile infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Diverticulitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Listeriosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Lung abscess
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Septic shock
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Device related infection
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Neutrophil count decreased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Starvation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Delirium
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Orthostatic hypotension
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
Other adverse events
| Measure |
Arm A (Experimental): MM-121 in Combination With Docetaxel
n=103 participants at risk
MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle
Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
Arm B (Comparator): Docetaxel Alone
n=49 participants at risk
Docetaxel (approved chemotherapy treatment for NSCLC):
75 mg/m˄2 IV on Day 1 of each 21-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.2%
29/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
22.4%
11/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.2%
29/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
22.4%
11/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
12.2%
6/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Tachycardia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Atrial flutter
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Cardio pulmonary failure
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Myocardial infarction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Endocrine disorders
Hypothyroidism
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Lacrimation increased
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Dry eye
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Blepharospasm
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Eye irritation
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Vision blurred
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Eye pruritus
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.5%
52/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
22.4%
11/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Nausea
|
29.1%
30/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
28.6%
14/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Stomatitis
|
18.4%
19/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
13/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Constipation
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
14.3%
7/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
5/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Colitis
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Odynophagia
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Dysphagia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Oral pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Anal fissure
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Duodenitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Glossodynia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Glossitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Fatigue
|
43.7%
45/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
32.7%
16/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Asthenia
|
27.2%
28/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
22.4%
11/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Gastrointestinal disorders
Mucosal inflammation
|
14.6%
15/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
10.2%
5/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Pyrexia
|
12.6%
13/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
18.4%
9/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Pain
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
12.2%
6/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Oedema peripheral
|
4.9%
5/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Chills
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Chest pain
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
General physical health deterioration
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Oedema
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
10.2%
5/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Xerosis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Ulcer
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Cyst
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Extravasation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Hernia pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Hyperthermia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Influenza like illness
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Otitis media
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Infusion site reaction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Gait disturbance
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Discomfort
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Local swelling
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
General disorders
Secretion discharge
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Immune system disorders
Seasonal allergy
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Pneumonia
|
11.7%
12/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
12.2%
6/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Respiratory tract infection
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Oral candidiasis
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Sepsis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Bronchitis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Candida infection
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Conjunctivitis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Herpes zoster
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Paronychia
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Oral herpes
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Clostridium difficile infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Fungal infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Influenza
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Rhinitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Appendicitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Diverticulitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Furuncle
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Listeriosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Lung abscess
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Mucosal infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Septic shock
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Tracheitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Vaginal infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Wound infection
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Nasopharyngitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Pharyngitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Sinusitis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Device related infection
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Ear infection
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Neutrophil count decreased
|
13.6%
14/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
White blood cell count decreased
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Weight decreased
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood creatinine increased
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Haemoglobin decreased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood magnesium decreased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Platelet count decreased
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood albumin decreased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood bilirubin increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood glucose increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood iron decreased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood phosphorus decreased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood sodium decreased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Breath sounds abnormal
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
International normalised ratio increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Lipase increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Transaminases increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Urine analysis abnormal
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Weight increased
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood creatine increased
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
White blood cell count increased
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.0%
34/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
16.3%
8/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
9/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
10.2%
5/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Gout
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Starvation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
8/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
9/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
8.2%
4/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Dizziness
|
11.7%
12/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
9/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Headache
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Paraesthesia
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Syncope
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Hemiparesis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Memory impairment
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Polyneuropathy
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Neurotoxicity
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Presyncope
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Somnolence
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Amnesia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Lethargy
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Paresis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Restless legs syndrome
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Sciatica
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Sinus headache
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Spinal cord compression
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Ataxia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Cognitive disorder
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Motor dysfunction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Confusional state
|
4.9%
5/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Insomnia
|
4.9%
5/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
10.2%
5/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Anxiety
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Delirium
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Agitation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Irritability
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Sleep disorder
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Haematuria
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Incontinence
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Renal failure acute
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Renal venous congestion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Urinary retention
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Renal and urinary disorders
Pollakiuria
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.4%
20/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
18.4%
9/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Hypertension
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
12/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
12.2%
6/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.7%
9/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.9%
5/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.9%
4/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.3%
23/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
26.5%
13/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
10/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
12.2%
6/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
6/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.9%
3/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
6.1%
3/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Surgical and medical procedures
Pain management
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Hypotension
|
6.8%
7/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Phlebitis
|
1.9%
2/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
4.1%
2/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Embolism
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Haematoma
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Haemorrhage
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Hot flush
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Ischaemia
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Flushing
|
0.97%
1/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
0.00%
0/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/103 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
2.0%
1/49 • From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019)
The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place